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
K
23
3855
AllPEP
2
Cleared 510(K)
K
22
1058
LungTrainer (MD2 & MD3)
2
Cleared 510(K)
K
22
2018
Breathe+
2
Cleared 510(K)
K
22
0565
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
2
Cleared 510(K)
K
20
3378
Pulsehaler
2
Cleared 510(K)
K
19
2000
D R Burton OxyPAP
2
Cleared 510(K)
K
18
1660
Acapella Choice Blue Vibratory PEP Device
2
Cleared 510(K)
K
18
3108
Combined Aerobika OPEP and VersaPAP device
2
Cleared 510(K)
K
18
2847
Hudson RCI Voldyne Volumetric Exerciser
2
Cleared 510(K)
K
17
3918
VersaPAP Positive Airway Pressure (PAP) Device
2
Cleared 510(K)
K
17
2388
VPOD ITPR
2
Cleared 510(K)
K
16
0837
MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
2
Cleared 510(K)
K
16
3091
VibraPEP
2
Cleared 510(K)
K
16
0636
iPEP System and vPEP
2
Cleared 510(K)
K
15
0044
O-PEP
2
Cleared 510(K)
K
15
3441
VibraPEP
2
Cleared 510(K)
K
15
0173
Aerobika OPEP Devive with Manometer
2
Cleared 510(K)
K
14
0772
AEROSURE MEDIC
2
Cleared 510(K)
K
14
1355
VOLUMETRIC INCENTIVE SPIROMETER
2
Cleared 510(K)
K
13
3873
TRIBALL INCENTIVE SPIROMETER
2
Cleared 510(K)
K
12
3400
AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
2
Cleared 510(K)
K
09
1557
LUNG FLUTE THERAPEUTIC
2
Cleared 510(K)
K
09
0829
PARI PEP S
2
Cleared 510(K)
K
08
0299
RESPIFIT S, MODEL RS-LR1001004
2
Cleared 510(K)
K
07
0490
CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)
2
Cleared 510(K)
K
05
3149
SPIRO-BALL
2
Cleared 510(K)
K
04
0084
LIFESTYLE CIRCULATORY ENHANCER
2
Cleared 510(K)
K
03
3401
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
2
Cleared 510(K)
K
02
2906
RESQPOD CIRCULATORY ENHANCER
2
Cleared 510(K)
K
01
2368
AEROPEP
2
Cleared 510(K)
K
00
2768
ACAPELLA
2
Cleared 510(K)
K
00
3146
CLINIFLO INCENTIVE SPIROMETER
2
Cleared 510(K)
K
99
4074
TRI-BALL
2
Cleared 510(K)
K
00
0314
INCENTIVE SPIROMETER
2
Cleared 510(K)
K
99
2256
FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
2
Cleared 510(K)
K
99
1561
ROADRUNNER, PEP THERAPY DEVICE
2
Cleared 510(K)
K
99
1300
BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
2
Cleared 510(K)
K
98
3308
RC CORNET, MODEL #44F50
2
Cleared 510(K)
K
98
4468
VITAL PEP
2
Cleared 510(K)
K
98
3467
THERAPEP
2
Cleared 510(K)
K
97
4848
MINI-CISER
2
Cleared 510(K)
K
97
2824
THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
2
Cleared 510(K)
K
97
2042
PARI PEP THERAPY SYSTEM
2
Cleared 510(K)
K
97
0596
DHD EMERALD PRODUCT
2
Cleared 510(K)
K
95
4492
MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
2
Cleared 510(K)
K
96
2749
THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT
2
Cleared 510(K)
K
96
1077
PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
2
Cleared 510(K)
K
95
3055
MISTASSIST BREATHING EXERCISER
2
Cleared 510(K)
K
94
4412
THE BREATHER
2
Cleared 510(K)
K
94
4344
LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER
2
Cleared 510(K)
K
94
5118
EXPIRATORY BREATHING EXERCISER
2
Cleared 510(K)
K
94
4900
THERAPEP
2
Cleared 510(K)
K
94
2919
MERCURY EXPIRATORY RESISTANCE EXERCISER
2
Cleared 510(K)
K
91
2943
THRESHOLD 2X INSPIRATORY MUSCLE TRAINER
2
Cleared 510(K)
K
91
0138
TVS II ELECTRONIC INCENTIVE SPIROMETER
2
Cleared 510(K)
K
90
3489
THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000
2
Cleared 510(K)
K
90
0754
RESPIREX 2
2
Cleared 510(K)
K
89
3665
AEROSOL INHALATION MONITOR
2
Cleared 510(K)
K
87
3540
AEROBICA - LUNG EXERCISER
2
Cleared 510(K)
K
87
3579
AMBU RMT VALVE
2
Cleared 510(K)
K
87
1904
TOTAL LUNG EXERCISER (TLE)
2
Cleared 510(K)
K
87
1742
MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER
2
Cleared 510(K)
K
87
0514
THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
2
Cleared 510(K)
K
86
4719
PFLEX EM(TM) (EXERCISE MONITOR)
2
Cleared 510(K)
K
86
1564
THE LUNG GYM (XLATOR AND NLATOR)
2
Cleared 510(K)
K
85
1334
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
2
Cleared 510(K)
K
84
4963
VITAPEP
2
Cleared 510(K)
K
84
2369
ELECATH INFANT ARTERIAL & VENOUS CANNU
2
Cleared 510(K)
K
84
2634
PFLEX RESPIRATORY MUSCLE EXERCISER
2
Cleared 510(K)
K
84
0239
VOFLEX
2
Cleared 510(K)
K
84
0418
INSPIRATORY/EXPIRATORY MUSCLE EXERCIS
2
Cleared 510(K)
K
83
3337
VOLUREX II
2
Cleared 510(K)
K
83
3012
INSPIROMETER
2
Cleared 510(K)
K
83
2878
GOAL TENDER
2
Cleared 510(K)
K
83
1142
INSPIRATORY RESISTOR KIT
2
Cleared 510(K)
K
82
1492
BE#6006 VAR. RESIS. INSPIR. MUSCLE
2
Cleared 510(K)
K
82
2359
SPI-RISE
2
Cleared 510(K)
K
82
1998
RESPICORD
2
Cleared 510(K)
K
82
0528
PFLEX TM
2
Cleared 510(K)
K
82
0606
MONAGHAN'S TRUE VOLUME EXERCISER
2
Cleared 510(K)
K
81
3476
OHIO VOLUME INCENTIVE SPIROMETER
2
Cleared 510(K)
K
81
0641
K-MED ENCOURAGER INCENTIVE SPIROMETER
2
Cleared 510(K)
K
80
1199
VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX
2
Cleared 510(K)
K
80
0546
BUNN VOLUMAIRE RESPIRATORY EXERCISER
2
Cleared 510(K)
K
80
0386
ARGYLE TRU-VOL
2
Cleared 510(K)
K
79
2598
DISPOSABLE INCENTIVE SPIROMETER
2
Cleared 510(K)
K
79
2571
COUNTER UNIT
2
Cleared 510(K)
K
79
2217
AIR INCENTIVE SPIROMETER, W/NEBULIZER
2
Cleared 510(K)
K
79
2214
MODEL TM2-BEHIND-THE-EAR TINNITUS
2
Cleared 510(K)
K
79
1842
MOTIVATOR
2
Cleared 510(K)
K
79
1819
AIR INCENTIVE SPIROMETER
2
Cleared 510(K)
K
79
1015
VOLUREX TM
2
Cleared 510(K)
K
79
0744
LUNG FUNCTION AMPLIFIER EXERCISER
2
Cleared 510(K)
K
78
1831
SPIROMETER, INCENTIVE CATALOG # 1750
2
Cleared 510(K)
K
78
2016
SPIROCARE 108-B
2
Cleared 510(K)
K
78
1731
INCENT-O-NEB
2
Cleared 510(K)
K
78
1838
CALCULATOR, WITH CHARGER
2
Cleared 510(K)
K
78
1833
EXERCISER, AIR-EZE INCENTIVE
2
Cleared 510(K)
K
78
1669
RESPIRATORY EXERCISOR, VOLUME PULSE
2
Cleared 510(K)
K
78
1245
LUNG EXER. BAG, POST-OP, MODIFIED
2
Cleared 510(K)
K
78
0265
FLOW REDUCING ANGULATION STAND
2
Cleared 510(K)
K
78
0037
EXERCISER, RESP., DEEP BREATHING
2
Cleared 510(K)
K
77
1532
SPIROMETEO & LUNG EXERCISER, 4601
2
Cleared 510(K)
K
77
0619
EXERCISOR, RESPIRATORY
2
Cleared 510(K)
K
77
0141
INSPIROMETER RESPIRATORY EXERCISER
2
Cleared 510(K)
K
76
0762
INCENTIVE SPIROMETER
2
Cleared 510(K)
K
76
0167
BAG, POST OPERATIVE LUNG EXERCIZING BLOW
2
Cleared 510(K)
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
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 30 November 2024 at 11:09 am
AN
/
subpart-f—therapeutic-devices
/
BWF
/
K012368
View Source
AEROPEP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K012368
510(k) Type
Traditional
Applicant
TRUDELL MEDICAL INTL.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
2/12/2002
Days to Decision
201 days
Submission Type
Statement
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)
K
23
3855
AllPEP
K
22
1058
LungTrainer (MD2 & MD3)
K
22
2018
Breathe+
K
22
0565
Hudson RCI Triflo II Incentive Deep Breathing Exerciser
K
20
3378
Pulsehaler
K
19
2000
D R Burton OxyPAP
K
18
1660
Acapella Choice Blue Vibratory PEP Device
K
18
3108
Combined Aerobika OPEP and VersaPAP device
K
18
2847
Hudson RCI Voldyne Volumetric Exerciser
K
17
3918
VersaPAP Positive Airway Pressure (PAP) Device
K
17
2388
VPOD ITPR
K
16
0837
MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM
K
16
3091
VibraPEP
K
16
0636
iPEP System and vPEP
K
15
0044
O-PEP
K
15
3441
VibraPEP
K
15
0173
Aerobika OPEP Devive with Manometer
K
14
0772
AEROSURE MEDIC
K
14
1355
VOLUMETRIC INCENTIVE SPIROMETER
K
13
3873
TRIBALL INCENTIVE SPIROMETER
K
12
3400
AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
K
09
1557
LUNG FLUTE THERAPEUTIC
K
09
0829
PARI PEP S
K
08
0299
RESPIFIT S, MODEL RS-LR1001004
K
07
0490
CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)
K
05
3149
SPIRO-BALL
K
04
0084
LIFESTYLE CIRCULATORY ENHANCER
K
03
3401
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
K
02
2906
RESQPOD CIRCULATORY ENHANCER
K
01
2368
AEROPEP
K
00
2768
ACAPELLA
K
00
3146
CLINIFLO INCENTIVE SPIROMETER
K
99
4074
TRI-BALL
K
00
0314
INCENTIVE SPIROMETER
K
99
2256
FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
K
99
1561
ROADRUNNER, PEP THERAPY DEVICE
K
99
1300
BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
K
98
3308
RC CORNET, MODEL #44F50
K
98
4468
VITAL PEP
K
98
3467
THERAPEP
K
97
4848
MINI-CISER
K
97
2824
THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER
K
97
2042
PARI PEP THERAPY SYSTEM
K
97
0596
DHD EMERALD PRODUCT
K
95
4492
MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
K
96
2749
THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORT
K
96
1077
PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
K
95
3055
MISTASSIST BREATHING EXERCISER
K
94
4412
THE BREATHER
K
94
4344
LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER
K
94
5118
EXPIRATORY BREATHING EXERCISER
K
94
4900
THERAPEP
K
94
2919
MERCURY EXPIRATORY RESISTANCE EXERCISER
K
91
2943
THRESHOLD 2X INSPIRATORY MUSCLE TRAINER
K
91
0138
TVS II ELECTRONIC INCENTIVE SPIROMETER
K
90
3489
THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000
K
90
0754
RESPIREX 2
K
89
3665
AEROSOL INHALATION MONITOR
K
87
3540
AEROBICA - LUNG EXERCISER
K
87
3579
AMBU RMT VALVE
K
87
1904
TOTAL LUNG EXERCISER (TLE)
K
87
1742
MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER
K
87
0514
THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER
K
86
4719
PFLEX EM(TM) (EXERCISE MONITOR)
K
86
1564
THE LUNG GYM (XLATOR AND NLATOR)
K
85
1334
AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
K
84
4963
VITAPEP
K
84
2369
ELECATH INFANT ARTERIAL & VENOUS CANNU
K
84
2634
PFLEX RESPIRATORY MUSCLE EXERCISER
K
84
0239
VOFLEX
K
84
0418
INSPIRATORY/EXPIRATORY MUSCLE EXERCIS
K
83
3337
VOLUREX II
K
83
3012
INSPIROMETER
K
83
2878
GOAL TENDER
K
83
1142
INSPIRATORY RESISTOR KIT
K
82
1492
BE#6006 VAR. RESIS. INSPIR. MUSCLE
K
82
2359
SPI-RISE
K
82
1998
RESPICORD
K
82
0528
PFLEX TM
K
82
0606
MONAGHAN'S TRUE VOLUME EXERCISER
K
81
3476
OHIO VOLUME INCENTIVE SPIROMETER
K
81
0641
K-MED ENCOURAGER INCENTIVE SPIROMETER
K
80
1199
VOLDYNE VOLUMETRIC INCENTIVE DEEP BR. EX
K
80
0546
BUNN VOLUMAIRE RESPIRATORY EXERCISER
K
80
0386
ARGYLE TRU-VOL
K
79
2598
DISPOSABLE INCENTIVE SPIROMETER
K
79
2571
COUNTER UNIT
K
79
2217
AIR INCENTIVE SPIROMETER, W/NEBULIZER
K
79
2214
MODEL TM2-BEHIND-THE-EAR TINNITUS
K
79
1842
MOTIVATOR
K
79
1819
AIR INCENTIVE SPIROMETER
K
79
1015
VOLUREX TM
K
79
0744
LUNG FUNCTION AMPLIFIER EXERCISER
K
78
1831
SPIROMETER, INCENTIVE CATALOG # 1750
K
78
2016
SPIROCARE 108-B
K
78
1731
INCENT-O-NEB
K
78
1838
CALCULATOR, WITH CHARGER
K
78
1833
EXERCISER, AIR-EZE INCENTIVE
K
78
1669
RESPIRATORY EXERCISOR, VOLUME PULSE
K
78
1245
LUNG EXER. BAG, POST-OP, MODIFIED
K
78
0265
FLOW REDUCING ANGULATION STAND
K
78
0037
EXERCISER, RESP., DEEP BREATHING
K
77
1532
SPIROMETEO & LUNG EXERCISER, 4601
K
77
0619
EXERCISOR, RESPIRATORY
K
77
0141
INSPIROMETER RESPIRATORY EXERCISER
K
76
0762
INCENTIVE SPIROMETER
K
76
0167
BAG, POST OPERATIVE LUNG EXERCIZING BLOW
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)
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
/
BWF
/
K012368
View Source
AEROPEP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K012368
510(k) Type
Traditional
Applicant
TRUDELL MEDICAL INTL.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
2/12/2002
Days to Decision
201 days
Submission Type
Statement