FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
BRW
Protector, Dental
1
Product Code
BSF
Absorber, Carbon-Dioxide
1
Product Code
BSJ
Mask, Gas, Anesthetic
1
Product Code
BSK
Cuff, Tracheal Tube, Inflatable
2
Product Code
BSN
Filter, Conduction, Anesthetic
2
Product Code
BSO
Catheter, Conduction, Anesthetic
2
Product Code
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
2
Product Code
BSR
Stylet, Tracheal Tube
1
Product Code
BSZ
Gas-Machine, Anesthesia
2
Product Code
BTB
Hook, Ether
1
Product Code
BTC
Bag, Reservoir
1
Product Code
BTK
Strap, Head, Gas Mask
1
Product Code
BTL
Ventilator, Emergency, Powered (Resuscitator)
2
Product Code
BTM
Ventilator, Emergency, Manual (Resuscitator)
2
Product Code
BTO
Tube, Tracheostomy (W/Wo Connector)
2
Product Code
BTP
Dropper, Ether
1
Product Code
BTQ
Airway, Nasopharyngeal
1
Product Code
BTR
Tube, Tracheal (W/Wo Connector)
2
Product Code
BTS
Tube, Bronchial (W/Wo Connector)
2
Product Code
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
2
Product Code
BWB
Forceps, Tube Introduction
1
Product Code
BWC
Needle, Emergency Airway
2
Product Code
BWF
Spirometer, Therapeutic (Incentive)
2
Product Code
BWL
Apparatus, Electronanesthesia
3
Product Code
BYD
Condenser, Heat And Moisture (Artificial Nose)
1
Product Code
BYE
Attachment, Breathing, Positive End Expiratory Pressure
2
Product Code
BYF
Mask, Oxygen, Low Concentration, Venturi
1
Product Code
BYG
Mask, Oxygen
1
Product Code
BYH
Drain, Tee (Water Trap)
1
Product Code
BYI
Percussor, Powered-Electric
2
Product Code
BYJ
Unit, Liquid-Oxygen, Portable
2
Product Code
BYK
Tent, Oxygen, Electrically Powered
2
Product Code
BYL
Tent, Oxygen
1
Product Code
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
1
Product Code
BYO
Bottle, Blow
1
Product Code
BYP
Mouthpiece, Breathing
1
Product Code
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
2
Product Code
BYW
Device, Rebreathing
1
Product Code
BYX
Tubing, Pressure And Accessories
1
Product Code
BZA
Connector, Airway (Extension)
1
Product Code
BZB
Catheter, Nasal, Oxygen
1
Product Code
BZD
Ventilator, Non-Continuous (Respirator)
2
Product Code
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
2
Product Code
BZO
Set, Tubing And Support, Ventilator (W Harness)
1
Product Code
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
2
Product Code
CAD
Vaporizer, Anesthesia, Non-Heated
2
Product Code
CAE
Airway, Oropharyngeal, Anesthesiology
1
Product Code
CAF
Nebulizer (Direct Patient Interface)
2
Product Code
K
23
3553
MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
2
Cleared 510(K)
K
23
2507
Aerogen®Solo Nebulizer System
2
Cleared 510(K)
K
23
2523
Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%
2
Cleared 510(K)
K
23
1058
Hudson RCI® AddiPak® Unit Dose Vial
2
Cleared 510(K)
K
23
0379
Portable (Ultrasonic) Nebulizer
2
Cleared 510(K)
K
23
0602
Hudson RCI® TurboMist™ Nebulizer System
2
Cleared 510(K)
K
22
3367
Ochsner Connected Inhaler Sensor
2
Cleared 510(K)
K
22
0145
Monaghan medical filtered mouthpiece kit
2
Cleared 510(K)
K
22
3840
eRapid Nebulizer System
2
Cleared 510(K)
K
22
3100
Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
2
Cleared 510(K)
K
22
0955
Hudson RCI Variable concentration Large Volume Nebulizer (1770)
2
Cleared 510(K)
K
22
2247
Hailie Sensor NF0110
2
Cleared 510(K)
K
22
0869
Vapotherm Aerosol Adapter AAA-2
2
Cleared 510(K)
K
22
1994
Hailie Sensor NF0107 & NF0108
2
Cleared 510(K)
K
22
0622
Hailie Sensor NF0106
2
Cleared 510(K)
K
21
2395
Nebulizer
2
Cleared 510(K)
K
21
1560
Airvo Nebulizer Adapter
2
Cleared 510(K)
K
21
0126
Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%
2
Cleared 510(K)
K
20
3155
BreatheSuite MDI V1
2
Cleared 510(K)
K
21
1233
Hailie Sensor NF0109
2
Cleared 510(K)
K
19
2971
Nebulizer Kit
2
Cleared 510(K)
K
20
2171
Pulmogine Vibrating Mesh Nebulizer
2
Cleared 510(K)
K
20
3400
Corrugated tube with mouthpiece accessory
2
Cleared 510(K)
K
20
1397
Ultrasonic Mesh Nebulizer
2
Cleared 510(K)
K
20
1167
AireHealth NebulizerTM
2
Cleared 510(K)
K
18
2906
Portable Mesh Nebulizer
2
Cleared 510(K)
K
20
0063
AeroEclipse* ONE BAN
2
Cleared 510(K)
K
19
2633
GUS831 Compressor Nebulizer
2
Cleared 510(K)
K
19
2724
Propeller Sensor for Symbicort
2
Cleared 510(K)
K
19
1270
Proneb Max
2
Cleared 510(K)
K
18
3586
CapMedic
2
Cleared 510(K)
K
18
2638
Hailie Sensor
2
Cleared 510(K)
K
18
2573
Hailie Sensor
2
Cleared 510(K)
K
18
1405
Hailie Sensor
2
Cleared 510(K)
K
18
0871
Portable Nebulizer
2
Cleared 510(K)
K
17
1549
Intelligent Mesh Nebulizer
2
Cleared 510(K)
K
18
0770
Propeller Sensor for Neohaler
2
Cleared 510(K)
K
18
0407
Smartinhaler
2
Cleared 510(K)
K
17
0886
HOMED Mesh Nebulizer
2
Cleared 510(K)
K
17
3825
MC 300R* Nebulizer
2
Cleared 510(K)
K
17
3310
SmartTouch
2
Cleared 510(K)
K
17
3367
MC 300* Nebulizer
2
Cleared 510(K)
K
17
0916
Portable Nebulizer
2
Cleared 510(K)
K
17
0853
InnoSpire Go
2
Cleared 510(K)
K
16
1586
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
2
Cleared 510(K)
K
16
3485
SmartTouch
2
Cleared 510(K)
K
15
3748
AirLife Misty Finity Nebulizer
2
Cleared 510(K)
K
16
2041
Airworks Nebulizer pe1200m
2
Cleared 510(K)
K
16
2785
Velox Nebulizer System
2
Cleared 510(K)
K
16
2753
RTC 26-C Inline Aerosol Adapter
2
Cleared 510(K)
K
16
1454
Propeller Sensor Model 2015-E
2
Cleared 510(K)
K
15
3010
Hudson RCI AquaPak Sterile Prefilled Nebulizers
2
Cleared 510(K)
K
15
2882
Propeller System
2
Cleared 510(K)
K
15
2482
Propeller Sensor Model 2014-R
2
Cleared 510(K)
K
14
2541
POCKET NEB
2
Cleared 510(K)
K
14
3719
Aeroneb USB Contoller System
2
Cleared 510(K)
K
15
0591
Besmed Reusable Jet Nebulizer
2
Cleared 510(K)
K
14
3671
Propeller Model 2014-D Sensor
2
Cleared 510(K)
K
14
2516
Propeller System
2
Cleared 510(K)
K
14
2153
HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
2
Cleared 510(K)
K
14
2960
Propeller System 2014-R
2
Cleared 510(K)
K
14
2059
FOX MOBILE
2
Cleared 510(K)
K
14
0237
DISPOSABLE NEBULIZER SET
2
Cleared 510(K)
K
14
1214
AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS
2
Cleared 510(K)
K
13
3360
AERONEB SOLO; AERONEB SOLO ADAPTER
2
Cleared 510(K)
K
14
1140
COMP A-I-R
2
Cleared 510(K)
K
14
0919
RESPICONNECT ADAPTER
2
Cleared 510(K)
K
13
3105
BREEZE NEBULIZER (NBR-10X)
2
Cleared 510(K)
K
14
0211
ULTRASONIC MESH NEBULIZER
2
Cleared 510(K)
K
14
0638
PROPELLER SYSTEM - MODEL 2
2
Cleared 510(K)
K
13
3951
SMARTTOUCH
2
Cleared 510(K)
K
13
2247
ULTRASONIC MESH NEBULIZER
2
Cleared 510(K)
K
12
3030
COMPRESSOR NEBULIZER MODEL MCN-S600XX
2
Cleared 510(K)
K
13
0379
ROLLINS 7 OXYGEN MASK
2
Cleared 510(K)
K
12
3527
AIRLIFE
2
Cleared 510(K)
K
12
1770
HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
2
Cleared 510(K)
K
12
2060
CLEVER TD-7001NEBULIZER
2
Cleared 510(K)
K
12
1520
ULTRASONIC NEBULIZER (MESH TYPE)
2
Cleared 510(K)
K
13
0091
PULMOSAL
2
Cleared 510(K)
K
12
3614
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
2
Cleared 510(K)
K
12
1969
U-RIGHT COMPRESSOR NEBULIZER
2
Cleared 510(K)
K
12
2857
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
2
Cleared 510(K)
K
12
1154
ULTRASONIC NEBULIZER
2
Cleared 510(K)
K
11
1246
SPIRALE DRUG DELIVERY SYSTEM
2
Cleared 510(K)
K
12
1609
ASTHMAPOLIS SYSTEM
2
Cleared 510(K)
K
11
2824
QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER
2
Cleared 510(K)
K
11
3033
SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
2
Cleared 510(K)
K
11
2859
ERAPID NEBULIZER SYSTEM
2
Cleared 510(K)
K
12
0939
AERONEB PRO
2
Cleared 510(K)
K
12
0051
SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
2
Cleared 510(K)
K
11
2041
KOO SMALL VOLUME NEBULIZER (SVN)
2
Cleared 510(K)
K
11
2564
QUIXIE NEBULIZER
2
Cleared 510(K)
K
10
2454
I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM
2
Cleared 510(K)
K
11
1570
MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
2
Cleared 510(K)
K
11
0860
COMP A-I-R
2
Cleared 510(K)
K
10
2719
ATLANTEAN TRIGGER NEBULIZER
2
Cleared 510(K)
K
11
0273
AEROVENT PLUS CHC
2
Cleared 510(K)
K
10
3635
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
2
Cleared 510(K)
K
10
1552
FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001
2
Cleared 510(K)
K
10
1953
SMDIA-1000
2
Cleared 510(K)
K
10
2658
MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS
2
Cleared 510(K)
K
10
2240
NIVO NEBULIZER SYSTEM
2
Cleared 510(K)
K
10
1424
PHARMACARIBE INHALED SALINE SOLUTIONS
2
Cleared 510(K)
K
10
1857
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
2
Cleared 510(K)
K
09
2859
MERITS MODEL N SERIES NEBULIZER COMPRESSORS
2
Cleared 510(K)
K
10
0285
LITETOUCH MASK
2
Cleared 510(K)
K
09
2560
PARI SINUS
2
Cleared 510(K)
K
10
0380
ALTERA NEBULIZER SYSTEM, MODEL 678G1002
2
Cleared 510(K)
K
09
2918
PARI VIOS
2
Cleared 510(K)
K
09
1794
CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202
2
Cleared 510(K)
K
09
1111
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
2
Cleared 510(K)
K
09
0730
AKITA JET
2
Cleared 510(K)
K
09
1272
BESMED JET NEBULIZER BOTTLE SET
2
Cleared 510(K)
K
09
1803
SMARTTRACK SYSTEM
2
Cleared 510(K)
K
08
3256
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
2
Cleared 510(K)
K
09
0840
VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.
2
Cleared 510(K)
K
09
0307
DDI ULTRASONIC NEBULIZER SYSTEM
2
Cleared 510(K)
K
09
0065
AEROCHAMBER MINI VENTILATION CHAMBER
2
Cleared 510(K)
K
08
2878
NEVONI CLASSIC, MODEL 6600-PO
2
Cleared 510(K)
K
08
2541
HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM
2
Cleared 510(K)
K
08
1650
AERONEB GO NEBULIZER
2
Cleared 510(K)
K
08
1738
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100
2
Cleared 510(K)
K
08
2009
HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
2
Cleared 510(K)
K
08
0926
AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER
2
Cleared 510(K)
K
08
0969
HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510
2
Cleared 510(K)
K
07
2136
ULTRASONIC NEBULISER MODEL 2010
2
Cleared 510(K)
K
08
0657
NEB-90 LARGE VOLUME MEDICATION NEBULIZER
2
Cleared 510(K)
K
08
0230
NEB-U-MASK SYSTEM, MODELS 1895, 1896
2
Cleared 510(K)
K
07
2163
HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
2
Cleared 510(K)
K
07
2494
AG-CLASSIC
2
Cleared 510(K)
K
06
3716
AEROSOL SYSTEM
2
Cleared 510(K)
K
07
2670
MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
2
Cleared 510(K)
K
07
2822
FUNHALER, MODEL V-201E
2
Cleared 510(K)
K
07
2019
AKITA2 APIXNEB
2
Cleared 510(K)
K
07
0411
AMSURE NEBULIZER
2
Cleared 510(K)
K
07
2418
OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER
2
Cleared 510(K)
K
07
2119
AIRLIFE NEBULIZER CAP
2
Cleared 510(K)
K
06
2484
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
2
Cleared 510(K)
K
07
0990
APEX MEDICAL MOBINEB, 9R-027 SERIES
2
Cleared 510(K)
K
07
0642
AERONEB PROFESSIONAL NEBULIZER SYSTEM
2
Cleared 510(K)
K
07
0498
HYPER SAL
2
Cleared 510(K)
K
07
0948
HSINER NEBULIZER BOTTLE
2
Cleared 510(K)
K
06
2014
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB
2
Cleared 510(K)
K
06
3449
DELUXE NEBULIZER
2
Cleared 510(K)
K
06
2263
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
2
Cleared 510(K)
K
06
2952
C300 SERIES AIR NEBULIZER COMPRESSOR
2
Cleared 510(K)
K
06
2689
SIDESTREAM PLUS
2
Cleared 510(K)
K
06
3103
AG-EDGE, MODEL 91200
2
Cleared 510(K)
K
06
2811
DPILOG, MODEL DPC-512
2
Cleared 510(K)
K
06
2158
LC SPRINT STAR
2
Cleared 510(K)
K
05
3490
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
2
Cleared 510(K)
K
06
0497
BABYAIR
2
Cleared 510(K)
K
06
0404
AG-PLUS, MODEL 91210
2
Cleared 510(K)
K
06
0842
REVJET TURBO
2
Cleared 510(K)
K
06
1381
LC STAR WITH NASAL ADAPTER
2
Cleared 510(K)
K
06
0811
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
2
Cleared 510(K)
K
06
0357
TREK S NEBULIZER COMPRESSOR
2
Cleared 510(K)
K
05
3360
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
2
Cleared 510(K)
K
06
0399
LC SPRINT NEBULIZER
2
Cleared 510(K)
K
05
3605
AEROECLIPSE II BREATH ACTUATED NEBULIZER
2
Cleared 510(K)
K
05
2438
EMG HANDLE NEBULIZER NB02 SERIES
2
Cleared 510(K)
K
05
2811
HSINER JET NEBULIZER, MODEL HS-31100
2
Cleared 510(K)
K
05
3203
MYNEB NEBULIZER, MODEL RDD100
2
Cleared 510(K)
K
05
2941
I-NEB INSIGHT AAD SYSTEM
2
Cleared 510(K)
K
04
2991
I-NEB AAD SYSTEM
2
Cleared 510(K)
K
05
1260
SCHUCO MIST AND SCHUCO DELUXE MIST
2
Cleared 510(K)
K
05
0183
SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES
2
Cleared 510(K)
K
05
1365
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
2
Cleared 510(K)
K
04
3238
COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES
2
Cleared 510(K)
K
05
1284
MD TURBO
2
Cleared 510(K)
K
05
0104
APEX MEDICAL MININEB & MINIPLUS
2
Cleared 510(K)
K
04
2483
INVACARE PRO, COMPACT AND PORTABLE DESKTOP
2
Cleared 510(K)
K
04
2546
FUNHALER, MODEL FH 101
2
Cleared 510(K)
K
04
2655
INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456
2
Cleared 510(K)
K
04
1079
GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103
2
Cleared 510(K)
K
04
1082
NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
2
Cleared 510(K)
K
03
1370
SHINMED MODE SW-988 UNTRASONIC NEBULIZER
2
Cleared 510(K)
K
04
1327
MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES
2
Cleared 510(K)
K
04
0439
MDI TRIGGER GUARD
2
Cleared 510(K)
K
04
1418
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
2
Cleared 510(K)
K
03
2170
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
2
Cleared 510(K)
K
03
0396
OMNI~NEB; OMNI~MAX
2
Cleared 510(K)
K
03
3833
EFLOW ELECTRONIC INHALER/NEBULIZER
2
Cleared 510(K)
K
03
0747
PRODOSE AAD SYSTEM
2
Cleared 510(K)
K
04
0718
TRUST
2
Cleared 510(K)
K
03
1982
BIRDSONG LEVERHALER, MODEL LH-1000
2
Cleared 510(K)
K
03
2516
HIOX80 AEROSOL ADAPTER
2
Cleared 510(K)
K
03
2972
AEROCHAMBER MAX VALVED HOLDING CHAMBER
2
Cleared 510(K)
K
03
1908
MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)
2
Cleared 510(K)
K
03
2849
AERONEB GO NEBULIZER, MODEL AG-AG2000
2
Cleared 510(K)
K
03
2809
HOSPITAL SPACER
2
Cleared 510(K)
K
03
0374
SONIK LDI 20 AIR
2
Cleared 510(K)
K
02
3602
SMALL VOLUME NEBULIZER
2
Cleared 510(K)
K
02
1742
GALEMED NEB-EASY NEBULIZER
2
Cleared 510(K)
K
02
1443
56 SERIES JET NEBULIZER
2
Cleared 510(K)
K
02
0357
800 SERIES EASYNEB NEBULIZER
2
Cleared 510(K)
K
02
0932
DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
2
Cleared 510(K)
K
02
1175
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
2
Cleared 510(K)
K
02
0944
VORTEX VALVED HOLDING CHAMBER
2
Cleared 510(K)
K
01
4056
SALTER LABS MODIFIED NEBUTECH NEBULIZER
2
Cleared 510(K)
K
01
2939
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
2
Cleared 510(K)
K
01
2006
MEDICAL DEPOT POWER NEB 1
2
Cleared 510(K)
K
00
2543
COMOACT ULTRASONIC NEBULIZER, MODEL 3060
2
Cleared 510(K)
K
01
0680
CT SPACER
2
Cleared 510(K)
K
00
2831
VEGA ULTRASONIC NEBULIZER
2
Cleared 510(K)
K
00
3344
MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
2
Cleared 510(K)
K
00
2153
ULTRASONIC NEBULIZER, MODEL NE-520
2
Cleared 510(K)
K
99
3101
LITEAIRE
2
Cleared 510(K)
K
00
3022
AERONEB PORTABLE NEBULIZER
2
Cleared 510(K)
K
99
2831
AERONEB II, MODEL APN 200
2
Cleared 510(K)
K
00
1137
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
2
Cleared 510(K)
K
00
0543
CONTEMPRO-MIST
2
Cleared 510(K)
K
99
0435
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
2
Cleared 510(K)
K
99
3492
DEVILBISS NEBULIZER MODEL 800
2
Cleared 510(K)
K
99
3199
POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER
2
Cleared 510(K)
K
99
4352
SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
2
Cleared 510(K)
K
99
0897
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
2
Cleared 510(K)
K
99
1355
METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
2
Cleared 510(K)
K
99
2285
SALTER AIRE COMPRESSOR
2
Cleared 510(K)
K
99
3558
EZFLOW MAX, MODEL 1007
2
Cleared 510(K)
K
99
2722
PRIMEAIRE
2
Cleared 510(K)
K
99
2643
MODEL IRC 1001 AEROSOL COMPRESSOR
2
Cleared 510(K)
K
99
2986
SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER
2
Cleared 510(K)
K
99
2917
AEROCHAMBER PLUS VALVED HOLDING CHAMBER
2
Cleared 510(K)
K
99
2038
POCKETSPACER
2
Cleared 510(K)
K
98
0024
SHINMED MODEL SW-966 ULTRASONIC NEBULIZER
2
Cleared 510(K)
K
99
1685
HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
2
Cleared 510(K)
K
99
1788
SALTER LABS PEP DEVICE
2
Cleared 510(K)
K
98
4085
RITEFLO SPACER
2
Cleared 510(K)
K
99
1725
SIDESTREAM NEBULIZER
2
Cleared 510(K)
K
99
0384
EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
2
Cleared 510(K)
K
98
2722
AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
2
Cleared 510(K)
K
99
0185
MDILOG, MODEL MDC-512
2
Cleared 510(K)
K
99
0506
MABIS NB-02 ULTRASONIC NEBULIZER
2
Cleared 510(K)
K
98
2181
TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER
2
Cleared 510(K)
K
97
1981
LS SERIES 200 FLOVISION SYSTEM
2
Cleared 510(K)
K
98
3403
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
2
Cleared 510(K)
K
98
1249
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D
2
Cleared 510(K)
K
98
3736
ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER
2
Cleared 510(K)
K
98
2043
BRENEB
2
Cleared 510(K)
K
98
1772
HALOLITE AAD SYSTEM
2
Cleared 510(K)
K
98
3002
MYSTIQUE ULTRASONIC NEBULIZER
2
Cleared 510(K)
K
98
2179
TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER
2
Cleared 510(K)
K
98
2408
AEROTEE, MODEL # 1001
2
Cleared 510(K)
K
98
1944
BREATHERITE
2
Cleared 510(K)
K
98
1167
STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT
2
Cleared 510(K)
K
98
0074
56 SERIES AEROSOL GENERATOR
2
Cleared 510(K)
K
98
0829
3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP
2
Cleared 510(K)
K
98
0407
HOPE NEBULIZER
2
Cleared 510(K)
K
97
3532
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
2
Cleared 510(K)
K
97
4379
ULTRANEB
2
Cleared 510(K)
K
97
2657
ULTRAMIST 2000
2
Cleared 510(K)
K
97
4056
0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP
2
Cleared 510(K)
K
97
3468
MODEL IRC 1199 SCOUT NEBULIZER
2
Cleared 510(K)
K
97
0844
ATOMISOR
2
Cleared 510(K)
K
97
2778
DEY VIAL SODIUM CHLORIDE 3%
2
Cleared 510(K)
K
97
1808
SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES
2
Cleared 510(K)
K
97
2467
STERILE WATER FOR INHALATION, USP
2
Cleared 510(K)
K
97
2466
SODIUM CHLORIDE INHALATION SOLUTION, USP
2
Cleared 510(K)
K
97
2371
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR
2
Cleared 510(K)
K
97
0344
MDILOG, MODEL MDC-511
2
Cleared 510(K)
K
97
1933
PORT-NEB
2
Cleared 510(K)
K
97
2237
HAND HELD MEDISPACER
2
Cleared 510(K)
K
97
0542
MASTER NEB II
2
Cleared 510(K)
K
96
3793
OPTIVENT
2
Cleared 510(K)
K
97
0289
COMPRESSOR/NEBULIZER #3650
2
Cleared 510(K)
K
97
0035
JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009
2
Cleared 510(K)
K
97
0010
FPT NEBULIZER
2
Cleared 510(K)
K
95
2910
THE SWIRLER NEBULIZER
2
Cleared 510(K)
K
96
2534
THERA-MIST NEBULIZER MODEL-P3000
2
Cleared 510(K)
K
96
3917
HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT
2
Cleared 510(K)
K
96
2874
RESPIFLO/S
2
Cleared 510(K)
K
96
2872
RESPIFLO
2
Cleared 510(K)
K
96
4994
CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR
2
Cleared 510(K)
K
96
2438
MISTY OX TURBOHEATER
2
Cleared 510(K)
K
96
4078
3050 SPORT-NEB
2
Cleared 510(K)
K
96
0854
SIEMENS SERVO ULTRA NEBULIZER 345
2
Cleared 510(K)
K
96
3910
HEART NEBULIZER #100609
2
Cleared 510(K)
K
96
3924
LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70
2
Cleared 510(K)
K
96
2879
SALTERLABS 8660 SERIES NEBULIZER
2
Cleared 510(K)
K
96
2822
OPTICHAMBER
2
Cleared 510(K)
K
96
2085
SALTER LABS 8990 SERIES NEBULIZER
2
Cleared 510(K)
K
96
2072
PRONEB TURBO COMPRESSOR MODEL 38V0200
2
Cleared 510(K)
K
96
2161
BAXTER NEBULIZER CAP MODEL 2D0868
2
Cleared 510(K)
K
96
1973
DHD ACE WITH MASK KIT
2
Cleared 510(K)
K
96
1476
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
2
Cleared 510(K)
K
95
5104
HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
2
Cleared 510(K)
K
96
0675
WALKHALER PORTABLE COMPRESSOR MODEL 45F70
2
Cleared 510(K)
K
96
0397
MEDICATOR AEROSOL DRUG DELIVERY SYSTEM
2
Cleared 510(K)
K
95
5805
DUAL SPRAY MINISPACER
2
Cleared 510(K)
K
95
2326
PULMOMIST
2
Cleared 510(K)
K
95
2249
JET NEBULIZER
2
Cleared 510(K)
K
94
1627
A&D UN-231 ULTRASONIC HANDY NEBULIZER
2
Cleared 510(K)
K
95
4327
MEDOX CHAMPION COMPACT NEBULIZER
2
Cleared 510(K)
K
95
2893
THE SWIRLER AEROSOL SYSTEM
2
Cleared 510(K)
K
93
3961
MARSAM MODEL 2000 NEBULIZER
2
Cleared 510(K)
K
94
3717
MASTER-NEB NEBULIZER COMPRESSOR SYSTEM
2
Cleared 510(K)
K
95
3206
DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)
2
Cleared 510(K)
K
95
0290
MEDI - PUMP
2
Cleared 510(K)
K
94
6095
DEVILBISS MODEL 5500
2
Cleared 510(K)
K
95
1259
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300
2
Cleared 510(K)
K
95
0867
MEDI - PUMP
2
Cleared 510(K)
K
94
3990
3000 AEROSOL TWO
2
Cleared 510(K)
K
93
5540
PARI-MASTER MODIFICATION
2
Cleared 510(K)
K
94
4020
AIRSEP NEWLIFE AIR OUTLET OPTION
2
Cleared 510(K)
K
94
2444
3002 AEROMAX
2
Cleared 510(K)
K
94
2208
4003 AEROLITE
2
Cleared 510(K)
K
95
0206
FISONEB(R) II
2
Cleared 510(K)
K
94
2384
ENDURANCE R3000
2
Cleared 510(K)
K
94
2350
CAREPAK
2
Cleared 510(K)
K
94
4152
PARI BABY
2
Cleared 510(K)
K
94
3600
UNIHEART
2
Cleared 510(K)
K
94
0257
HAND-HELD NEBULIZER
2
Cleared 510(K)
K
94
4643
AUTONEB ACCESSORY CROSS (AAC)
2
Cleared 510(K)
K
93
5955
DOSER
2
Cleared 510(K)
K
93
5693
AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT
2
Cleared 510(K)
K
93
4749
FREEWAY LITE NEBULIZER COMPRESSOR
2
Cleared 510(K)
K
92
1273
EASIMIST ULTRASONIC NEBULIZER
2
Cleared 510(K)
K
92
6280
STANDARD NEBULIZER HEATER
2
Cleared 510(K)
K
93
3090
EZ-SPACER
2
Cleared 510(K)
K
93
3535
VENTSTREAM DRUG NEBULIZER
2
Cleared 510(K)
K
93
0574
AEROCHAMBER W/MASK, MODIFIED
2
Cleared 510(K)
K
93
3915
VENTI-GENTLE-HALER(TM)
2
Cleared 510(K)
K
92
3559
STERI-CATH MDI
2
Cleared 510(K)
K
93
0525
MICRO MIST(TM) NEBULIZER
2
Cleared 510(K)
K
92
6455
PARI FILTER/VALVE SET
2
Cleared 510(K)
K
92
4667
AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY)
2
Cleared 510(K)
K
92
6301
ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO
2
Cleared 510(K)
K
93
0949
VOYAGE
2
Cleared 510(K)
K
93
0947
PROMENADE
2
Cleared 510(K)
K
92
4649
SOFT-MIST(TM)
2
Cleared 510(K)
K
93
1603
MILLIPORE RT-100 AEROSOL RETENTION FILTER
2
Cleared 510(K)
K
92
4535
THAYER HAND HELD M.K.I. HOLDING CHAMBER
2
Cleared 510(K)
K
92
3888
DEVILBISS MODEL 5650 PULMO-AIDE
2
Cleared 510(K)
K
92
3698
BETAMIST 2
2
Cleared 510(K)
K
92
6055
THE MILLER NEBULIZER SYSTEM
2
Cleared 510(K)
K
92
3324
PRECISION MIST COMPRESSOR
2
Cleared 510(K)
K
92
4684
MICROFLOW
2
Cleared 510(K)
K
92
1809
COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
2
Cleared 510(K)
K
91
3095
SAM LS
2
Cleared 510(K)
K
91
3096
SAM SC
2
Cleared 510(K)
K
92
2187
COMPACT SPACER
2
Cleared 510(K)
K
92
4123
SIDESTREAM DISPOSABLE
2
Cleared 510(K)
K
92
4081
LUMISONIC
2
Cleared 510(K)
K
92
3690
MINI HEART
2
Cleared 510(K)
K
92
3596
HEART NEBULIZER
2
Cleared 510(K)
K
92
1339
HAND-E-BREATH
2
Cleared 510(K)
K
92
3024
NE-U04/NE U04F
2
Cleared 510(K)
K
92
2923
NE-U07
2
Cleared 510(K)
K
91
4772
MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001
2
Cleared 510(K)
K
91
5075
NEBULIZER (DIRECT PATIENT INTERFACE)
2
Cleared 510(K)
K
92
0443
MININEB
2
Cleared 510(K)
K
92
0332
HEART NUBULIZER
2
Cleared 510(K)
K
91
5211
MICROCHAMBER
2
Cleared 510(K)
K
91
4836
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
2
Cleared 510(K)
K
91
4152
SIDESTREAM DRUG NEBULIZER
2
Cleared 510(K)
K
91
4465
AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000
2
Cleared 510(K)
K
91
4283
THAYER EXPANSION CHAMBER METERED DOSE INHALER
2
Cleared 510(K)
K
91
2805
PARI-MASTER
2
Cleared 510(K)
K
91
3326
DHD METERED DOSE INHALER (MDI) SPACER
2
Cleared 510(K)
K
91
3316
DEVILBISS MODEL 7427D
2
Cleared 510(K)
K
91
1192
DP 100
2
Cleared 510(K)
K
91
3015
HEART NEBULIZER FLOWMETER ADAPTOR
2
Cleared 510(K)
K
91
1807
METERED DOSE INHALER (MDI) SPACER
2
Cleared 510(K)
K
91
1422
DRUG NEBULIZERS
2
Cleared 510(K)
K
91
3220
AEROSOL MASKS, 81426, 81476, 81490 & 81492
2
Cleared 510(K)
K
91
1785
RHINO-GUARD
2
Cleared 510(K)
K
91
1759
VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER
2
Cleared 510(K)
K
91
2566
MINITROP AEROSOL UNIT
2
Cleared 510(K)
K
91
3000
HEART NEBULIZER POLE CLAMP
2
Cleared 510(K)
K
91
1896
DEVILBISS MODEL 5000
2
Cleared 510(K)
K
90
4398
WATER COLUMN RELIEF VALVE
2
Cleared 510(K)
K
90
4718
AERO-GEN NUBULIZER SYSTEM
2
Cleared 510(K)
K
90
4717
MICRO-VENT NEBULIZER SYSTEM
2
Cleared 510(K)
K
90
3499
MINI-MICRON CIRCUIT
2
Cleared 510(K)
K
90
4716
AERO-GEN NEBULIZER
2
Cleared 510(K)
K
90
4715
OXYGEN/AIR TUBING
2
Cleared 510(K)
K
90
3580
MICRO-MISTER
2
Cleared 510(K)
K
90
4196
MICRO-MIST NEBULIZER
2
Cleared 510(K)
K
89
6375
PREEMICARE NEBUTECH NEBULIZER SYSTEM
2
Cleared 510(K)
K
90
3413
MICROSPACER TM
2
Cleared 510(K)
K
90
1315
AEROMIST II NEBULIZER
2
Cleared 510(K)
K
90
0273
TRACH CARE MDI ADAPTER
2
Cleared 510(K)
K
89
6536
PHARMATRONICS NEBULIZER
2
Cleared 510(K)
K
90
0783
MDI ADAPTOR
2
Cleared 510(K)
K
90
1362
ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
2
Cleared 510(K)
K
90
1301
STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
2
Cleared 510(K)
K
90
1114
MEDISONIC HUMDIFIER/INHALER
2
Cleared 510(K)
K
90
0470
IN-THE NEBULIZER
2
Cleared 510(K)
K
90
0228
H.E.A.R.T. NEBULIZER
2
Cleared 510(K)
K
89
6923
INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT
2
Cleared 510(K)
K
89
6984
PARI I.S.-2
2
Cleared 510(K)
K
89
6696
(HEART) NEBULIZER
2
Cleared 510(K)
K
89
6192
MEDISONIC PNEU-NEB
2
Cleared 510(K)
K
89
5913
STANDARD NEBULIZER HEATER
2
Cleared 510(K)
K
89
4961
MEDISONIC ULTRA-SONIC INHALER
2
Cleared 510(K)
K
89
5231
CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
2
Cleared 510(K)
K
89
4138
MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
2
Cleared 510(K)
K
89
3942
THERA-MIST(TM) NEBULIZER, MODEL 30000
2
Cleared 510(K)
K
88
4803
AEROCHAMBER M.V.
2
Cleared 510(K)
K
88
4947
HAND HELD NEBULIZER SYSTEM
2
Cleared 510(K)
K
88
2936
ADJUSTABLE ENTRAINMENT NEBULIZER
2
Cleared 510(K)
K
88
1648
TRANSFER CONTAINER HUMIDIFIER
2
Cleared 510(K)
K
88
2935
NEBULIZER HEATER
2
Cleared 510(K)
K
88
4359
UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA.
2
Cleared 510(K)
K
88
4051
DSM-1 DOSIMETER
2
Cleared 510(K)
K
87
5134
OMRON ULTRASONIC NEBULIZER NE-U06
2
Cleared 510(K)
K
88
3964
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
2
Cleared 510(K)
K
88
2953
HYDRAMED BY LECHLER
2
Cleared 510(K)
K
88
1935
MICROCIRRUS MEDICAL NEBULIZER
2
Cleared 510(K)
K
88
0473
AERO-MIST NEBULIZER HEATER
2
Cleared 510(K)
K
88
0304
INSPIRON NEBULO BASIC EXTERNAL HEATER
2
Cleared 510(K)
K
87
3521
BRONCHODILATOR TEE - 9056 SERIES
2
Cleared 510(K)
K
88
0411
DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE
2
Cleared 510(K)
K
87
4047
ASTHMAKIT
2
Cleared 510(K)
K
87
4082
PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT
2
Cleared 510(K)
K
87
4041
DEVILBISS MODEL 8500D
2
Cleared 510(K)
K
87
4395
RESPIRGARD II NEBULIZER SYSTEM
2
Cleared 510(K)
K
87
3930
AEROSOL DELIVERY SYSTEM (AERO-TECH II)
2
Cleared 510(K)
K
87
3395
HOYER SOLVET
2
Cleared 510(K)
K
87
1427
(SPAG) MODEL SPAG-2 6000 SERIES
2
Cleared 510(K)
K
87
0051
SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE
2
Cleared 510(K)
K
87
2826
ULTRA-NEB 99 ULTRASONIC NEBULIZER
2
Cleared 510(K)
K
87
1293
SERVO NEBULIZER 945 SIEMENS-ELEMA AB
2
Cleared 510(K)
K
86
4466
OMRON ULTRASONIC NEBULIZER MODEL NE-UO5
2
Cleared 510(K)
K
85
1436
NEBULAIRE (IRC 1040) NEBULIZER PUMP
2
Cleared 510(K)
K
85
1074
VARIABLE NEBULIZER HEATER
2
Cleared 510(K)
K
80
0023
LUNG AEROSOL UNIT
2
Cleared 510(K)
K
83
4077
SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN
2
Cleared 510(K)
K
83
3922
BRETHANCER, DRUG DELIVERY SYS-INHAL
2
Cleared 510(K)
K
83
2898
NEBULIZER ACCESSORY FOR SERVO VENTILL
2
Cleared 510(K)
K
83
2086
USE 77 ULTRASONIC NEBULIZER
2
Cleared 510(K)
K
83
1270
DISPOS. MEDICATION NEBULIZER
2
Cleared 510(K)
K
83
1162
ENERGETIC HI-HUM AERSOL UNIT
2
Cleared 510(K)
K
83
0943
PREFILLED RESPIRATORY THERAPY VIAL
2
Cleared 510(K)
K
83
0895
SINGLE USE NEBULIZER, ADJUST. AIR-
2
Cleared 510(K)
K
82
1129
AIRLIFE NEBULIZER HEATER
2
Cleared 510(K)
K
82
1191
STER-O-MIST 1000 ML
2
Cleared 510(K)
K
82
0952
OPTI-MIST
2
Cleared 510(K)
K
82
0227
STER-O-DOSE
2
Cleared 510(K)
K
81
0218
PREFILLED NEBULIZER
2
Cleared 510(K)
K
81
0217
NEBULIZER HEATER
2
Cleared 510(K)
K
80
2477
MISTY NEBULIZER
2
Cleared 510(K)
K
80
1875
CIRCUITS, BREATHING W/CONNECTORS, ADAPT
2
Cleared 510(K)
K
80
0830
SIEMENS-ELECTROGERATE GMBH MICRO-INHALER
2
Cleared 510(K)
K
80
0562
DISPOSABLE HAND HELD NEBULIZER
2
Cleared 510(K)
K
80
0294
0.45% SODIUM CHLORIDE SOL./RESP. THERAPY
2
Cleared 510(K)
K
80
0295
0.9% SODIUM CHLORIDE SOL./RESP. THERAPY
2
Cleared 510(K)
K
80
0083
NEBULIZER TUBING SET
2
Cleared 510(K)
K
79
2364
TEE ADAPTER
2
Cleared 510(K)
K
79
2218
MISTY BEBULIZER
2
Cleared 510(K)
K
79
1820
I.P.P.B. MANIFOLDS & NEB. SING. & DBL
2
Cleared 510(K)
K
79
1536
DISPOSABLE MEDICATION NEBULIZER
2
Cleared 510(K)
K
79
1443
TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINE
2
Cleared 510(K)
K
79
1445
TWO-PIECE IPPB MANIFOLD MACHINES
2
Cleared 510(K)
K
79
1444
UNIVERSAL TWO-PIECE MACHINES
2
Cleared 510(K)
K
79
1218
INHALATION OPERATED NEBULIZER CODE
2
Cleared 510(K)
K
79
0892
MISTY NEBULIZER
2
Cleared 510(K)
K
79
1089
SHERWOOD NEBULIZER KIT
2
Cleared 510(K)
K
79
0982
INSPIRON NEBULO TM 28 NEBULIZER KIT
2
Cleared 510(K)
K
79
1042
I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL
2
Cleared 510(K)
K
79
0926
NEBULIZER WITH MOUTHPIECE AND TEE
2
Cleared 510(K)
K
79
0925
NEBULIZER WITH 4-WAY T NO M-174
2
Cleared 510(K)
K
79
0924
NEBULIZER NO. M-175
2
Cleared 510(K)
K
79
0153
MANIFOLD, W/CORRUGATED TUBING
2
Cleared 510(K)
K
79
0154
MANIFOLD, FOR DOUBLE SUPPLY
2
Cleared 510(K)
K
79
0152
MANIFOLD, UNIVERSAL I.P.P.B
2
Cleared 510(K)
K
78
1485
PATIENT CIRCUIT MANIFOLD
2
Cleared 510(K)
K
78
1542
HEATED NEBULIZER
2
Cleared 510(K)
K
78
1467
U-FLOAT VALVE 2D9023
2
Cleared 510(K)
K
78
0668
SOLUTIONS FOR RESPIRATORY THERAPY
2
Cleared 510(K)
K
78
0456
NEBULIZER HEATER
2
Cleared 510(K)
K
78
0406
2C7153 NEBULIZER CAP
2
Cleared 510(K)
K
78
0119
NEBULIZER, DISP, 2D0815
2
Cleared 510(K)
K
78
0264
NEBULIZATION KIT & ADAPTER KIT
2
Cleared 510(K)
K
77
2294
INSPIRON MANIFOLD (DOUBLE)
2
Cleared 510(K)
K
77
2296
INSPIRON MANIFOLD
2
Cleared 510(K)
K
77
2295
INSPIRON MANIFOLD (SINGLE)
2
Cleared 510(K)
K
77
2348
NEBULIZER ADAPTER
2
Cleared 510(K)
K
77
2222
NEBULIZER SET-2C7105
2
Cleared 510(K)
K
77
2068
MANIFOLD & NEBULIZER, UNIVERSAL
2
Cleared 510(K)
K
77
2072
MANIFOLD & NEBU. FOR DOUB. LINE MACH.
2
Cleared 510(K)
K
77
2071
MANIFOLD & NEBU. FOR SINGLE LINE MACH.
2
Cleared 510(K)
K
77
2070
VENTILATOR SETUP, VOLUME
2
Cleared 510(K)
K
77
1550
MRT DISPENSOR
2
Cleared 510(K)
K
77
1105
NEBULIZER, MOLEL 503, PART #17068
2
Cleared 510(K)
K
77
1061
ODUFLEX AEROSOL SET
2
Cleared 510(K)
K
77
0664
NEBULIZER
2
Cleared 510(K)
K
77
0828
NEBULIZER HEATER
2
Cleared 510(K)
K
77
0633
BRACKET BE 122-1
2
Cleared 510(K)
K
76
1298
PRE-FILLED DISPOSABLE NEBULIZER
2
Cleared 510(K)
K
76
1300
NEBULIZER CONTROL UNIT
2
Cleared 510(K)
K
76
1299
DISPOSABLE NEBULIZER
2
Cleared 510(K)
K
76
0964
ADDI-MIST
2
Cleared 510(K)
K
76
0845
SOLO-SPHERE HEATER
2
Cleared 510(K)
K
76
0585
U-MID PREFILLED NEBULIZER
2
Cleared 510(K)
K
76
0489
NEBULIZER, HANDHELD (T UP-DRAFT)
2
Cleared 510(K)
K
76
0442
NEBULIZER ADAPTER (AERMIST)
2
Cleared 510(K)
K
76
0335
NEBULIZER, MICRO (ADDI-MIST)
2
Cleared 510(K)
K
76
0095
RESPIRIZOR
2
Cleared 510(K)
CAG
Circulator, Breathing-Circuit
2
Product Code
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
1
Product Code
CAL
Laryngoscope, Non-Rigid
1
Product Code
CAO
Airway, Esophageal (Obturator)
2
Product Code
CAT
Cannula, Nasal, Oxygen
1
Product Code
CAW
Generator, Oxygen, Portable
2
Product Code
CAZ
Anesthesia Conduction Kit
2
Product Code
CBF
Chamber, Hyperbaric
2
Product Code
CBG
Spreader, Cuff
1
Product Code
CBH
Device, Fixation, Tracheal Tube
1
Product Code
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
2
Product Code
CBK
Ventilator, Continuous, Facility Use
2
Product Code
CBL
Absorbent, Carbon-Dioxide
1
Product Code
CBN
Apparatus, Gas-Scavenging
2
Product Code
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
2
Product Code
CBP
Valve, Non-Rebreathing
2
Product Code
MOD
Accessory To Continuous Ventilator (Respirator)
2
Product Code
CCO
Bed, Rocking, Breathing Assist
2
Product Code
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
1
Product Code
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
2
Product Code
CCW
Laryngoscope, Rigid
1
Product Code
EPE
Brush, Cleaning, Tracheal Tube
1
Product Code
FNC
Tent, Pediatric Aerosol
2
Product Code
FOG
Hood, Oxygen, Infant
1
Product Code
JAY
Support, Breathing Tube
1
Product Code
JOH
Tube Tracheostomy And Tube Cuff
2
Product Code
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
1
Product Code
KGB
Mask, Oxygen, Non-Rebreathing
1
Product Code
KHA
Mask, Scavenging
1
Product Code
LNZ
Changer, Tube, Endotracheal
2
Product Code
MIA
Needle, Spinal, Short Term
2
Product Code
MNS
Ventilator, Continuous, Non-Life-Supporting
2
Product Code
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
2
Product Code
MRN
Apparatus, Nitric Oxide Delivery
2
Product Code
MRO
Apparatus, Nitric Oxide, Backup Delivery
2
Product Code
MZT
Device, Heimlich Maneuver Assist
2
Product Code
NFB
Conserver, Oxygen
2
Product Code
NHJ
Device, Positive Pressure Breathing, Intermittent
2
Product Code
NHK
Resuscitator, Manual, Non Self-Inflating
2
Product Code
NMA
Tube, Tracheal, Reprocessed
2
Product Code
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
2
Product Code
NMR
Needle, Spinal, Short Term, Reprocessed
2
Product Code
NNH
Needle, Conduction, Anesthesia, Reprocessed
2
Product Code
NOU
Continuous, Ventilator, Home Use
2
Product Code
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
2
Product Code
NVO
Spacer, Direct Patient Interface
2
Product Code
NVP
Holding Chambers, Direct Patient Interface
2
Product Code
NXA
Tracheotomy Care Kit
2
Product Code
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
2
Product Code
OFQ
Anesthesia Kit
2
Product Code
OFT
Spinal Epidural Anesthesia Kit
2
Product Code
OFU
Spinal Anesthesia Kit
2
Product Code
OFV
Regional Anesthesia Kit
2
Product Code
OGA
Brachial Plexus Anesthesia Kit
2
Product Code
OGB
Caudal Anesthesia Kit
2
Product Code
OGC
Continuous Brachial Plexus Block Tray
2
Product Code
OGD
Custom Anesthesia Tray
2
Product Code
OGE
Epidural Anesthesia Kit
2
Product Code
OGF
Glossopharyngeal Anesthesia Kit
2
Product Code
OGG
Humidifier Nebulizer Kit
2
Product Code
OGH
Laryngoscope Kit
1
Product Code
OGI
Nasal Endotracheal Tube Holder Kit
1
Product Code
OGJ
Nerve Block Tray
2
Product Code
OGL
Oxygen Administration Kit
2
Product Code
OLF
Medevac Use Oxygen Generator
2
Product Code
ONZ
Mechanical Ventilator
2
Product Code
OQU
Airway Monitoring System
2
Product Code
PHS
Oral Airway Assist
1
Product Code
PMB
External Airway
2
Product Code
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
2
Product Code
QBY
Positive Airway Pressure System
2
Product Code
QCX
Retrograde Intubation Set
2
Product Code
OZR
Intraoral Pressure Gradient Device
2
Product Code
QFB
Isocapnic Ventilation Device
2
Product Code
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
CAF
/
K091111
View Source
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K091111
510(k) Type
Traditional
Applicant
INSTRUMENTATION INDUSTRIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/2/2009
Days to Decision
229 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
BRW
Protector, Dental
BSF
Absorber, Carbon-Dioxide
BSJ
Mask, Gas, Anesthetic
BSK
Cuff, Tracheal Tube, Inflatable
BSN
Filter, Conduction, Anesthetic
BSO
Catheter, Conduction, Anesthetic
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
BSR
Stylet, Tracheal Tube
BSZ
Gas-Machine, Anesthesia
BTB
Hook, Ether
BTC
Bag, Reservoir
BTK
Strap, Head, Gas Mask
BTL
Ventilator, Emergency, Powered (Resuscitator)
BTM
Ventilator, Emergency, Manual (Resuscitator)
BTO
Tube, Tracheostomy (W/Wo Connector)
BTP
Dropper, Ether
BTQ
Airway, Nasopharyngeal
BTR
Tube, Tracheal (W/Wo Connector)
BTS
Tube, Bronchial (W/Wo Connector)
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
BWB
Forceps, Tube Introduction
BWC
Needle, Emergency Airway
BWF
Spirometer, Therapeutic (Incentive)
BWL
Apparatus, Electronanesthesia
BYD
Condenser, Heat And Moisture (Artificial Nose)
BYE
Attachment, Breathing, Positive End Expiratory Pressure
BYF
Mask, Oxygen, Low Concentration, Venturi
BYG
Mask, Oxygen
BYH
Drain, Tee (Water Trap)
BYI
Percussor, Powered-Electric
BYJ
Unit, Liquid-Oxygen, Portable
BYK
Tent, Oxygen, Electrically Powered
BYL
Tent, Oxygen
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
BYO
Bottle, Blow
BYP
Mouthpiece, Breathing
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
BYW
Device, Rebreathing
BYX
Tubing, Pressure And Accessories
BZA
Connector, Airway (Extension)
BZB
Catheter, Nasal, Oxygen
BZD
Ventilator, Non-Continuous (Respirator)
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZO
Set, Tubing And Support, Ventilator (W Harness)
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
CAD
Vaporizer, Anesthesia, Non-Heated
CAE
Airway, Oropharyngeal, Anesthesiology
CAF
Nebulizer (Direct Patient Interface)
K
23
3553
MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
K
23
2507
Aerogen®Solo Nebulizer System
K
23
2523
Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%
K
23
1058
Hudson RCI® AddiPak® Unit Dose Vial
K
23
0379
Portable (Ultrasonic) Nebulizer
K
23
0602
Hudson RCI® TurboMist™ Nebulizer System
K
22
3367
Ochsner Connected Inhaler Sensor
K
22
0145
Monaghan medical filtered mouthpiece kit
K
22
3840
eRapid Nebulizer System
K
22
3100
Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
K
22
0955
Hudson RCI Variable concentration Large Volume Nebulizer (1770)
K
22
2247
Hailie Sensor NF0110
K
22
0869
Vapotherm Aerosol Adapter AAA-2
K
22
1994
Hailie Sensor NF0107 & NF0108
K
22
0622
Hailie Sensor NF0106
K
21
2395
Nebulizer
K
21
1560
Airvo Nebulizer Adapter
K
21
0126
Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%
K
20
3155
BreatheSuite MDI V1
K
21
1233
Hailie Sensor NF0109
K
19
2971
Nebulizer Kit
K
20
2171
Pulmogine Vibrating Mesh Nebulizer
K
20
3400
Corrugated tube with mouthpiece accessory
K
20
1397
Ultrasonic Mesh Nebulizer
K
20
1167
AireHealth NebulizerTM
K
18
2906
Portable Mesh Nebulizer
K
20
0063
AeroEclipse* ONE BAN
K
19
2633
GUS831 Compressor Nebulizer
K
19
2724
Propeller Sensor for Symbicort
K
19
1270
Proneb Max
K
18
3586
CapMedic
K
18
2638
Hailie Sensor
K
18
2573
Hailie Sensor
K
18
1405
Hailie Sensor
K
18
0871
Portable Nebulizer
K
17
1549
Intelligent Mesh Nebulizer
K
18
0770
Propeller Sensor for Neohaler
K
18
0407
Smartinhaler
K
17
0886
HOMED Mesh Nebulizer
K
17
3825
MC 300R* Nebulizer
K
17
3310
SmartTouch
K
17
3367
MC 300* Nebulizer
K
17
0916
Portable Nebulizer
K
17
0853
InnoSpire Go
K
16
1586
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)
K
16
3485
SmartTouch
K
15
3748
AirLife Misty Finity Nebulizer
K
16
2041
Airworks Nebulizer pe1200m
K
16
2785
Velox Nebulizer System
K
16
2753
RTC 26-C Inline Aerosol Adapter
K
16
1454
Propeller Sensor Model 2015-E
K
15
3010
Hudson RCI AquaPak Sterile Prefilled Nebulizers
K
15
2882
Propeller System
K
15
2482
Propeller Sensor Model 2014-R
K
14
2541
POCKET NEB
K
14
3719
Aeroneb USB Contoller System
K
15
0591
Besmed Reusable Jet Nebulizer
K
14
3671
Propeller Model 2014-D Sensor
K
14
2516
Propeller System
K
14
2153
HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
K
14
2960
Propeller System 2014-R
K
14
2059
FOX MOBILE
K
14
0237
DISPOSABLE NEBULIZER SET
K
14
1214
AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS
K
13
3360
AERONEB SOLO; AERONEB SOLO ADAPTER
K
14
1140
COMP A-I-R
K
14
0919
RESPICONNECT ADAPTER
K
13
3105
BREEZE NEBULIZER (NBR-10X)
K
14
0211
ULTRASONIC MESH NEBULIZER
K
14
0638
PROPELLER SYSTEM - MODEL 2
K
13
3951
SMARTTOUCH
K
13
2247
ULTRASONIC MESH NEBULIZER
K
12
3030
COMPRESSOR NEBULIZER MODEL MCN-S600XX
K
13
0379
ROLLINS 7 OXYGEN MASK
K
12
3527
AIRLIFE
K
12
1770
HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
K
12
2060
CLEVER TD-7001NEBULIZER
K
12
1520
ULTRASONIC NEBULIZER (MESH TYPE)
K
13
0091
PULMOSAL
K
12
3614
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
K
12
1969
U-RIGHT COMPRESSOR NEBULIZER
K
12
2857
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
K
12
1154
ULTRASONIC NEBULIZER
K
11
1246
SPIRALE DRUG DELIVERY SYSTEM
K
12
1609
ASTHMAPOLIS SYSTEM
K
11
2824
QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER
K
11
3033
SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
K
11
2859
ERAPID NEBULIZER SYSTEM
K
12
0939
AERONEB PRO
K
12
0051
SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML
K
11
2041
KOO SMALL VOLUME NEBULIZER (SVN)
K
11
2564
QUIXIE NEBULIZER
K
10
2454
I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM
K
11
1570
MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
K
11
0860
COMP A-I-R
K
10
2719
ATLANTEAN TRIGGER NEBULIZER
K
11
0273
AEROVENT PLUS CHC
K
10
3635
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S
K
10
1552
FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001
K
10
1953
SMDIA-1000
K
10
2658
MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS
K
10
2240
NIVO NEBULIZER SYSTEM
K
10
1424
PHARMACARIBE INHALED SALINE SOLUTIONS
K
10
1857
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
K
09
2859
MERITS MODEL N SERIES NEBULIZER COMPRESSORS
K
10
0285
LITETOUCH MASK
K
09
2560
PARI SINUS
K
10
0380
ALTERA NEBULIZER SYSTEM, MODEL 678G1002
K
09
2918
PARI VIOS
K
09
1794
CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202
K
09
1111
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
K
09
0730
AKITA JET
K
09
1272
BESMED JET NEBULIZER BOTTLE SET
K
09
1803
SMARTTRACK SYSTEM
K
08
3256
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
K
09
0840
VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.
K
09
0307
DDI ULTRASONIC NEBULIZER SYSTEM
K
09
0065
AEROCHAMBER MINI VENTILATION CHAMBER
K
08
2878
NEVONI CLASSIC, MODEL 6600-PO
K
08
2541
HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM
K
08
1650
AERONEB GO NEBULIZER
K
08
1738
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100
K
08
2009
HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
K
08
0926
AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER
K
08
0969
HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510
K
07
2136
ULTRASONIC NEBULISER MODEL 2010
K
08
0657
NEB-90 LARGE VOLUME MEDICATION NEBULIZER
K
08
0230
NEB-U-MASK SYSTEM, MODELS 1895, 1896
K
07
2163
HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
K
07
2494
AG-CLASSIC
K
06
3716
AEROSOL SYSTEM
K
07
2670
MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
K
07
2822
FUNHALER, MODEL V-201E
K
07
2019
AKITA2 APIXNEB
K
07
0411
AMSURE NEBULIZER
K
07
2418
OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER
K
07
2119
AIRLIFE NEBULIZER CAP
K
06
2484
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
K
07
0990
APEX MEDICAL MOBINEB, 9R-027 SERIES
K
07
0642
AERONEB PROFESSIONAL NEBULIZER SYSTEM
K
07
0498
HYPER SAL
K
07
0948
HSINER NEBULIZER BOTTLE
K
06
2014
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB
K
06
3449
DELUXE NEBULIZER
K
06
2263
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
K
06
2952
C300 SERIES AIR NEBULIZER COMPRESSOR
K
06
2689
SIDESTREAM PLUS
K
06
3103
AG-EDGE, MODEL 91200
K
06
2811
DPILOG, MODEL DPC-512
K
06
2158
LC SPRINT STAR
K
05
3490
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
K
06
0497
BABYAIR
K
06
0404
AG-PLUS, MODEL 91210
K
06
0842
REVJET TURBO
K
06
1381
LC STAR WITH NASAL ADAPTER
K
06
0811
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
K
06
0357
TREK S NEBULIZER COMPRESSOR
K
05
3360
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
K
06
0399
LC SPRINT NEBULIZER
K
05
3605
AEROECLIPSE II BREATH ACTUATED NEBULIZER
K
05
2438
EMG HANDLE NEBULIZER NB02 SERIES
K
05
2811
HSINER JET NEBULIZER, MODEL HS-31100
K
05
3203
MYNEB NEBULIZER, MODEL RDD100
K
05
2941
I-NEB INSIGHT AAD SYSTEM
K
04
2991
I-NEB AAD SYSTEM
K
05
1260
SCHUCO MIST AND SCHUCO DELUXE MIST
K
05
0183
SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES
K
05
1365
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
K
04
3238
COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES
K
05
1284
MD TURBO
K
05
0104
APEX MEDICAL MININEB & MINIPLUS
K
04
2483
INVACARE PRO, COMPACT AND PORTABLE DESKTOP
K
04
2546
FUNHALER, MODEL FH 101
K
04
2655
INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456
K
04
1079
GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103
K
04
1082
NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
K
03
1370
SHINMED MODE SW-988 UNTRASONIC NEBULIZER
K
04
1327
MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES
K
04
0439
MDI TRIGGER GUARD
K
04
1418
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
K
03
2170
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
K
03
0396
OMNI~NEB; OMNI~MAX
K
03
3833
EFLOW ELECTRONIC INHALER/NEBULIZER
K
03
0747
PRODOSE AAD SYSTEM
K
04
0718
TRUST
K
03
1982
BIRDSONG LEVERHALER, MODEL LH-1000
K
03
2516
HIOX80 AEROSOL ADAPTER
K
03
2972
AEROCHAMBER MAX VALVED HOLDING CHAMBER
K
03
1908
MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)
K
03
2849
AERONEB GO NEBULIZER, MODEL AG-AG2000
K
03
2809
HOSPITAL SPACER
K
03
0374
SONIK LDI 20 AIR
K
02
3602
SMALL VOLUME NEBULIZER
K
02
1742
GALEMED NEB-EASY NEBULIZER
K
02
1443
56 SERIES JET NEBULIZER
K
02
0357
800 SERIES EASYNEB NEBULIZER
K
02
0932
DEVILBISS PULMO-AIDE COMPACT COMPRESSOR
K
02
1175
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
K
02
0944
VORTEX VALVED HOLDING CHAMBER
K
01
4056
SALTER LABS MODIFIED NEBUTECH NEBULIZER
K
01
2939
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
K
01
2006
MEDICAL DEPOT POWER NEB 1
K
00
2543
COMOACT ULTRASONIC NEBULIZER, MODEL 3060
K
01
0680
CT SPACER
K
00
2831
VEGA ULTRASONIC NEBULIZER
K
00
3344
MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
K
00
2153
ULTRASONIC NEBULIZER, MODEL NE-520
K
99
3101
LITEAIRE
K
00
3022
AERONEB PORTABLE NEBULIZER
K
99
2831
AERONEB II, MODEL APN 200
K
00
1137
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
K
00
0543
CONTEMPRO-MIST
K
99
0435
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100
K
99
3492
DEVILBISS NEBULIZER MODEL 800
K
99
3199
POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER
K
99
4352
SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
K
99
0897
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
K
99
1355
METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
K
99
2285
SALTER AIRE COMPRESSOR
K
99
3558
EZFLOW MAX, MODEL 1007
K
99
2722
PRIMEAIRE
K
99
2643
MODEL IRC 1001 AEROSOL COMPRESSOR
K
99
2986
SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER
K
99
2917
AEROCHAMBER PLUS VALVED HOLDING CHAMBER
K
99
2038
POCKETSPACER
K
98
0024
SHINMED MODEL SW-966 ULTRASONIC NEBULIZER
K
99
1685
HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
K
99
1788
SALTER LABS PEP DEVICE
K
98
4085
RITEFLO SPACER
K
99
1725
SIDESTREAM NEBULIZER
K
99
0384
EZFLOW CONTINUOUS NEBULIZER,MODEL 1005
K
98
2722
AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
K
99
0185
MDILOG, MODEL MDC-512
K
99
0506
MABIS NB-02 ULTRASONIC NEBULIZER
K
98
2181
TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER
K
97
1981
LS SERIES 200 FLOVISION SYSTEM
K
98
3403
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
K
98
1249
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D
K
98
3736
ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER
K
98
2043
BRENEB
K
98
1772
HALOLITE AAD SYSTEM
K
98
3002
MYSTIQUE ULTRASONIC NEBULIZER
K
98
2179
TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER
K
98
2408
AEROTEE, MODEL # 1001
K
98
1944
BREATHERITE
K
98
1167
STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT
K
98
0074
56 SERIES AEROSOL GENERATOR
K
98
0829
3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP
K
98
0407
HOPE NEBULIZER
K
97
3532
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
K
97
4379
ULTRANEB
K
97
2657
ULTRAMIST 2000
K
97
4056
0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP
K
97
3468
MODEL IRC 1199 SCOUT NEBULIZER
K
97
0844
ATOMISOR
K
97
2778
DEY VIAL SODIUM CHLORIDE 3%
K
97
1808
SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES
K
97
2467
STERILE WATER FOR INHALATION, USP
K
97
2466
SODIUM CHLORIDE INHALATION SOLUTION, USP
K
97
2371
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR
K
97
0344
MDILOG, MODEL MDC-511
K
97
1933
PORT-NEB
K
97
2237
HAND HELD MEDISPACER
K
97
0542
MASTER NEB II
K
96
3793
OPTIVENT
K
97
0289
COMPRESSOR/NEBULIZER #3650
K
97
0035
JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009
K
97
0010
FPT NEBULIZER
K
95
2910
THE SWIRLER NEBULIZER
K
96
2534
THERA-MIST NEBULIZER MODEL-P3000
K
96
3917
HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT
K
96
2874
RESPIFLO/S
K
96
2872
RESPIFLO
K
96
4994
CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR
K
96
2438
MISTY OX TURBOHEATER
K
96
4078
3050 SPORT-NEB
K
96
0854
SIEMENS SERVO ULTRA NEBULIZER 345
K
96
3910
HEART NEBULIZER #100609
K
96
3924
LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70
K
96
2879
SALTERLABS 8660 SERIES NEBULIZER
K
96
2822
OPTICHAMBER
K
96
2085
SALTER LABS 8990 SERIES NEBULIZER
K
96
2072
PRONEB TURBO COMPRESSOR MODEL 38V0200
K
96
2161
BAXTER NEBULIZER CAP MODEL 2D0868
K
96
1973
DHD ACE WITH MASK KIT
K
96
1476
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
K
95
5104
HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
K
96
0675
WALKHALER PORTABLE COMPRESSOR MODEL 45F70
K
96
0397
MEDICATOR AEROSOL DRUG DELIVERY SYSTEM
K
95
5805
DUAL SPRAY MINISPACER
K
95
2326
PULMOMIST
K
95
2249
JET NEBULIZER
K
94
1627
A&D UN-231 ULTRASONIC HANDY NEBULIZER
K
95
4327
MEDOX CHAMPION COMPACT NEBULIZER
K
95
2893
THE SWIRLER AEROSOL SYSTEM
K
93
3961
MARSAM MODEL 2000 NEBULIZER
K
94
3717
MASTER-NEB NEBULIZER COMPRESSOR SYSTEM
K
95
3206
DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)
K
95
0290
MEDI - PUMP
K
94
6095
DEVILBISS MODEL 5500
K
95
1259
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300
K
95
0867
MEDI - PUMP
K
94
3990
3000 AEROSOL TWO
K
93
5540
PARI-MASTER MODIFICATION
K
94
4020
AIRSEP NEWLIFE AIR OUTLET OPTION
K
94
2444
3002 AEROMAX
K
94
2208
4003 AEROLITE
K
95
0206
FISONEB(R) II
K
94
2384
ENDURANCE R3000
K
94
2350
CAREPAK
K
94
4152
PARI BABY
K
94
3600
UNIHEART
K
94
0257
HAND-HELD NEBULIZER
K
94
4643
AUTONEB ACCESSORY CROSS (AAC)
K
93
5955
DOSER
K
93
5693
AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT
K
93
4749
FREEWAY LITE NEBULIZER COMPRESSOR
K
92
1273
EASIMIST ULTRASONIC NEBULIZER
K
92
6280
STANDARD NEBULIZER HEATER
K
93
3090
EZ-SPACER
K
93
3535
VENTSTREAM DRUG NEBULIZER
K
93
0574
AEROCHAMBER W/MASK, MODIFIED
K
93
3915
VENTI-GENTLE-HALER(TM)
K
92
3559
STERI-CATH MDI
K
93
0525
MICRO MIST(TM) NEBULIZER
K
92
6455
PARI FILTER/VALVE SET
K
92
4667
AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY)
K
92
6301
ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO
K
93
0949
VOYAGE
K
93
0947
PROMENADE
K
92
4649
SOFT-MIST(TM)
K
93
1603
MILLIPORE RT-100 AEROSOL RETENTION FILTER
K
92
4535
THAYER HAND HELD M.K.I. HOLDING CHAMBER
K
92
3888
DEVILBISS MODEL 5650 PULMO-AIDE
K
92
3698
BETAMIST 2
K
92
6055
THE MILLER NEBULIZER SYSTEM
K
92
3324
PRECISION MIST COMPRESSOR
K
92
4684
MICROFLOW
K
92
1809
COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)
K
91
3095
SAM LS
K
91
3096
SAM SC
K
92
2187
COMPACT SPACER
K
92
4123
SIDESTREAM DISPOSABLE
K
92
4081
LUMISONIC
K
92
3690
MINI HEART
K
92
3596
HEART NEBULIZER
K
92
1339
HAND-E-BREATH
K
92
3024
NE-U04/NE U04F
K
92
2923
NE-U07
K
91
4772
MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001
K
91
5075
NEBULIZER (DIRECT PATIENT INTERFACE)
K
92
0443
MININEB
K
92
0332
HEART NUBULIZER
K
91
5211
MICROCHAMBER
K
91
4836
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
K
91
4152
SIDESTREAM DRUG NEBULIZER
K
91
4465
AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000
K
91
4283
THAYER EXPANSION CHAMBER METERED DOSE INHALER
K
91
2805
PARI-MASTER
K
91
3326
DHD METERED DOSE INHALER (MDI) SPACER
K
91
3316
DEVILBISS MODEL 7427D
K
91
1192
DP 100
K
91
3015
HEART NEBULIZER FLOWMETER ADAPTOR
K
91
1807
METERED DOSE INHALER (MDI) SPACER
K
91
1422
DRUG NEBULIZERS
K
91
3220
AEROSOL MASKS, 81426, 81476, 81490 & 81492
K
91
1785
RHINO-GUARD
K
91
1759
VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER
K
91
2566
MINITROP AEROSOL UNIT
K
91
3000
HEART NEBULIZER POLE CLAMP
K
91
1896
DEVILBISS MODEL 5000
K
90
4398
WATER COLUMN RELIEF VALVE
K
90
4718
AERO-GEN NUBULIZER SYSTEM
K
90
4717
MICRO-VENT NEBULIZER SYSTEM
K
90
3499
MINI-MICRON CIRCUIT
K
90
4716
AERO-GEN NEBULIZER
K
90
4715
OXYGEN/AIR TUBING
K
90
3580
MICRO-MISTER
K
90
4196
MICRO-MIST NEBULIZER
K
89
6375
PREEMICARE NEBUTECH NEBULIZER SYSTEM
K
90
3413
MICROSPACER TM
K
90
1315
AEROMIST II NEBULIZER
K
90
0273
TRACH CARE MDI ADAPTER
K
89
6536
PHARMATRONICS NEBULIZER
K
90
0783
MDI ADAPTOR
K
90
1362
ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
K
90
1301
STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
K
90
1114
MEDISONIC HUMDIFIER/INHALER
K
90
0470
IN-THE NEBULIZER
K
90
0228
H.E.A.R.T. NEBULIZER
K
89
6923
INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT
K
89
6984
PARI I.S.-2
K
89
6696
(HEART) NEBULIZER
K
89
6192
MEDISONIC PNEU-NEB
K
89
5913
STANDARD NEBULIZER HEATER
K
89
4961
MEDISONIC ULTRA-SONIC INHALER
K
89
5231
CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
K
89
4138
MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
K
89
3942
THERA-MIST(TM) NEBULIZER, MODEL 30000
K
88
4803
AEROCHAMBER M.V.
K
88
4947
HAND HELD NEBULIZER SYSTEM
K
88
2936
ADJUSTABLE ENTRAINMENT NEBULIZER
K
88
1648
TRANSFER CONTAINER HUMIDIFIER
K
88
2935
NEBULIZER HEATER
K
88
4359
UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA.
K
88
4051
DSM-1 DOSIMETER
K
87
5134
OMRON ULTRASONIC NEBULIZER NE-U06
K
88
3964
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K
88
2953
HYDRAMED BY LECHLER
K
88
1935
MICROCIRRUS MEDICAL NEBULIZER
K
88
0473
AERO-MIST NEBULIZER HEATER
K
88
0304
INSPIRON NEBULO BASIC EXTERNAL HEATER
K
87
3521
BRONCHODILATOR TEE - 9056 SERIES
K
88
0411
DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE
K
87
4047
ASTHMAKIT
K
87
4082
PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT
K
87
4041
DEVILBISS MODEL 8500D
K
87
4395
RESPIRGARD II NEBULIZER SYSTEM
K
87
3930
AEROSOL DELIVERY SYSTEM (AERO-TECH II)
K
87
3395
HOYER SOLVET
K
87
1427
(SPAG) MODEL SPAG-2 6000 SERIES
K
87
0051
SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE
K
87
2826
ULTRA-NEB 99 ULTRASONIC NEBULIZER
K
87
1293
SERVO NEBULIZER 945 SIEMENS-ELEMA AB
K
86
4466
OMRON ULTRASONIC NEBULIZER MODEL NE-UO5
K
85
1436
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K
85
1074
VARIABLE NEBULIZER HEATER
K
80
0023
LUNG AEROSOL UNIT
K
83
4077
SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN
K
83
3922
BRETHANCER, DRUG DELIVERY SYS-INHAL
K
83
2898
NEBULIZER ACCESSORY FOR SERVO VENTILL
K
83
2086
USE 77 ULTRASONIC NEBULIZER
K
83
1270
DISPOS. MEDICATION NEBULIZER
K
83
1162
ENERGETIC HI-HUM AERSOL UNIT
K
83
0943
PREFILLED RESPIRATORY THERAPY VIAL
K
83
0895
SINGLE USE NEBULIZER, ADJUST. AIR-
K
82
1129
AIRLIFE NEBULIZER HEATER
K
82
1191
STER-O-MIST 1000 ML
K
82
0952
OPTI-MIST
K
82
0227
STER-O-DOSE
K
81
0218
PREFILLED NEBULIZER
K
81
0217
NEBULIZER HEATER
K
80
2477
MISTY NEBULIZER
K
80
1875
CIRCUITS, BREATHING W/CONNECTORS, ADAPT
K
80
0830
SIEMENS-ELECTROGERATE GMBH MICRO-INHALER
K
80
0562
DISPOSABLE HAND HELD NEBULIZER
K
80
0294
0.45% SODIUM CHLORIDE SOL./RESP. THERAPY
K
80
0295
0.9% SODIUM CHLORIDE SOL./RESP. THERAPY
K
80
0083
NEBULIZER TUBING SET
K
79
2364
TEE ADAPTER
K
79
2218
MISTY BEBULIZER
K
79
1820
I.P.P.B. MANIFOLDS & NEB. SING. & DBL
K
79
1536
DISPOSABLE MEDICATION NEBULIZER
K
79
1443
TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINE
K
79
1445
TWO-PIECE IPPB MANIFOLD MACHINES
K
79
1444
UNIVERSAL TWO-PIECE MACHINES
K
79
1218
INHALATION OPERATED NEBULIZER CODE
K
79
0892
MISTY NEBULIZER
K
79
1089
SHERWOOD NEBULIZER KIT
K
79
0982
INSPIRON NEBULO TM 28 NEBULIZER KIT
K
79
1042
I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL
K
79
0926
NEBULIZER WITH MOUTHPIECE AND TEE
K
79
0925
NEBULIZER WITH 4-WAY T NO M-174
K
79
0924
NEBULIZER NO. M-175
K
79
0153
MANIFOLD, W/CORRUGATED TUBING
K
79
0154
MANIFOLD, FOR DOUBLE SUPPLY
K
79
0152
MANIFOLD, UNIVERSAL I.P.P.B
K
78
1485
PATIENT CIRCUIT MANIFOLD
K
78
1542
HEATED NEBULIZER
K
78
1467
U-FLOAT VALVE 2D9023
K
78
0668
SOLUTIONS FOR RESPIRATORY THERAPY
K
78
0456
NEBULIZER HEATER
K
78
0406
2C7153 NEBULIZER CAP
K
78
0119
NEBULIZER, DISP, 2D0815
K
78
0264
NEBULIZATION KIT & ADAPTER KIT
K
77
2294
INSPIRON MANIFOLD (DOUBLE)
K
77
2296
INSPIRON MANIFOLD
K
77
2295
INSPIRON MANIFOLD (SINGLE)
K
77
2348
NEBULIZER ADAPTER
K
77
2222
NEBULIZER SET-2C7105
K
77
2068
MANIFOLD & NEBULIZER, UNIVERSAL
K
77
2072
MANIFOLD & NEBU. FOR DOUB. LINE MACH.
K
77
2071
MANIFOLD & NEBU. FOR SINGLE LINE MACH.
K
77
2070
VENTILATOR SETUP, VOLUME
K
77
1550
MRT DISPENSOR
K
77
1105
NEBULIZER, MOLEL 503, PART #17068
K
77
1061
ODUFLEX AEROSOL SET
K
77
0664
NEBULIZER
K
77
0828
NEBULIZER HEATER
K
77
0633
BRACKET BE 122-1
K
76
1298
PRE-FILLED DISPOSABLE NEBULIZER
K
76
1300
NEBULIZER CONTROL UNIT
K
76
1299
DISPOSABLE NEBULIZER
K
76
0964
ADDI-MIST
K
76
0845
SOLO-SPHERE HEATER
K
76
0585
U-MID PREFILLED NEBULIZER
K
76
0489
NEBULIZER, HANDHELD (T UP-DRAFT)
K
76
0442
NEBULIZER ADAPTER (AERMIST)
K
76
0335
NEBULIZER, MICRO (ADDI-MIST)
K
76
0095
RESPIRIZOR
CAG
Circulator, Breathing-Circuit
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
CAL
Laryngoscope, Non-Rigid
CAO
Airway, Esophageal (Obturator)
CAT
Cannula, Nasal, Oxygen
CAW
Generator, Oxygen, Portable
CAZ
Anesthesia Conduction Kit
CBF
Chamber, Hyperbaric
CBG
Spreader, Cuff
CBH
Device, Fixation, Tracheal Tube
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
CBK
Ventilator, Continuous, Facility Use
CBL
Absorbent, Carbon-Dioxide
CBN
Apparatus, Gas-Scavenging
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
CBP
Valve, Non-Rebreathing
MOD
Accessory To Continuous Ventilator (Respirator)
CCO
Bed, Rocking, Breathing Assist
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
CCW
Laryngoscope, Rigid
EPE
Brush, Cleaning, Tracheal Tube
FNC
Tent, Pediatric Aerosol
FOG
Hood, Oxygen, Infant
JAY
Support, Breathing Tube
JOH
Tube Tracheostomy And Tube Cuff
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
KGB
Mask, Oxygen, Non-Rebreathing
KHA
Mask, Scavenging
LNZ
Changer, Tube, Endotracheal
MIA
Needle, Spinal, Short Term
MNS
Ventilator, Continuous, Non-Life-Supporting
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
MRN
Apparatus, Nitric Oxide Delivery
MRO
Apparatus, Nitric Oxide, Backup Delivery
MZT
Device, Heimlich Maneuver Assist
NFB
Conserver, Oxygen
NHJ
Device, Positive Pressure Breathing, Intermittent
NHK
Resuscitator, Manual, Non Self-Inflating
NMA
Tube, Tracheal, Reprocessed
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
NMR
Needle, Spinal, Short Term, Reprocessed
NNH
Needle, Conduction, Anesthesia, Reprocessed
NOU
Continuous, Ventilator, Home Use
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NVO
Spacer, Direct Patient Interface
NVP
Holding Chambers, Direct Patient Interface
NXA
Tracheotomy Care Kit
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
OFQ
Anesthesia Kit
OFT
Spinal Epidural Anesthesia Kit
OFU
Spinal Anesthesia Kit
OFV
Regional Anesthesia Kit
OGA
Brachial Plexus Anesthesia Kit
OGB
Caudal Anesthesia Kit
OGC
Continuous Brachial Plexus Block Tray
OGD
Custom Anesthesia Tray
OGE
Epidural Anesthesia Kit
OGF
Glossopharyngeal Anesthesia Kit
OGG
Humidifier Nebulizer Kit
OGH
Laryngoscope Kit
OGI
Nasal Endotracheal Tube Holder Kit
OGJ
Nerve Block Tray
OGL
Oxygen Administration Kit
OLF
Medevac Use Oxygen Generator
ONZ
Mechanical Ventilator
OQU
Airway Monitoring System
PHS
Oral Airway Assist
PMB
External Airway
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
QBY
Positive Airway Pressure System
QCX
Retrograde Intubation Set
OZR
Intraoral Pressure Gradient Device
QFB
Isocapnic Ventilation Device
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-f—therapeutic-devices
/
CAF
/
K091111
View Source
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K091111
510(k) Type
Traditional
Applicant
INSTRUMENTATION INDUSTRIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/2/2009
Days to Decision
229 days
Submission Type
Summary