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
CAG
Circulator, Breathing-Circuit
2
Product Code
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
1
Product Code
K
95
4480
CONDENSATE COLLECTION KIT
1
Cleared 510(K)
K
95
3787
UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
95
3788
UNICOR, INC. GAS SAMPLING LINES & CONNECTORS
1
Cleared 510(K)
K
95
2020
PRIMA PEDIATRIC ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
95
2019
PRIMA ADULT GAS SAMPLING CIRCUITS
1
Cleared 510(K)
K
95
2014
PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
95
2018
PRIMA COAXIAL CIRCUITS
1
Cleared 510(K)
K
95
2017
PRIMA MAPLESON D CIRCUIT
1
Cleared 510(K)
K
95
2016
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS
1
Cleared 510(K)
K
95
2009
PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS
1
Cleared 510(K)
K
94
5565
SPIRO-FLEX
1
Cleared 510(K)
K
93
2288
NEONATAL BREATHING CIRCUIT MODIFICATION
1
Cleared 510(K)
K
94
5984
MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS
1
Cleared 510(K)
K
94
4533
PRIMA, INC. ADULT ANESTHESIA CIRCUIT
1
Cleared 510(K)
K
94
5314
CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING
1
Cleared 510(K)
K
94
4429
PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING
1
Cleared 510(K)
K
94
0889
CONNECTORS AND AIRWAY EXTENSIONS
1
Cleared 510(K)
K
94
0890
CORRUGATED TUBING
1
Cleared 510(K)
K
94
4295
KARL STORZ LARYNGOSCOPE ACCESSORIES
1
Cleared 510(K)
K
94
2135
M.A.G. INC. COAXIAL CIRCUITS
1
Cleared 510(K)
K
94
2134
M.A.G. INC. BREALTHING BAGS
1
Cleared 510(K)
K
94
2122
PEDIATRIC ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
94
2123
M.A.G. INC. VENTILATOR HOSES
1
Cleared 510(K)
K
94
2124
GAS SAMPLING LINES AND CONNECTORS CIRCUITS
1
Cleared 510(K)
K
94
2125
VOLUME VENTILATOR
1
Cleared 510(K)
K
94
2126
M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
94
2127
M.A.G INC. PEDIATRIC GAS SAMPLING CIRCUITS
1
Cleared 510(K)
K
94
2128
M.A.G. INC. ADULT GAS SAMPLING CIRCUITS
1
Cleared 510(K)
K
94
2129
M.A.G INC. ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
94
2130
M.A.G. INC. MAPLESON D CIRCUITS
1
Cleared 510(K)
K
94
2131
M.A.G. INC. GUEDEL AIRWAYS
1
Cleared 510(K)
K
94
2132
M.A.G. INC. HYPERINFLATION SYSTEM
1
Cleared 510(K)
K
94
2133
M.A.G. INC. CUSTOM ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
94
2136
M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS
1
Cleared 510(K)
K
94
2570
MAPLESON D CIRCUIT
1
Cleared 510(K)
K
94
2568
ADULT ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
93
4462
ADULT ANESTHESIA BREATHING CIRCUIT KITS
1
Cleared 510(K)
K
93
5168
ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS
1
Cleared 510(K)
K
93
2781
DUAL VALVED RESPIRATORY T
1
Cleared 510(K)
K
93
2780
MALE/MALE LUER TRANSFER TUBING
1
Cleared 510(K)
K
93
1487
BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE
1
Cleared 510(K)
K
93
5044
EASYFLOW AIRWAY ADAPTER
1
Cleared 510(K)
K
93
3641
BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE
1
Cleared 510(K)
K
93
0713
THE INFANT FLOW SYSTEM
1
Cleared 510(K)
K
93
2708
PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS
1
Cleared 510(K)
K
93
2707
ADULT ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
93
2710
GAS SAMPLING LINES AND CONNECTORS
1
Cleared 510(K)
K
93
2562
GAS SAMPLING LINES AND CONNECTORS
1
Cleared 510(K)
K
93
2590
ADULT GAS SAMPLING CIRCUITS
1
Cleared 510(K)
K
93
2577
PEDIATRIC GAS SAMPLING
1
Cleared 510(K)
K
93
2589
PEDIATRIC GAS SAMPLING CIRCUITS
1
Cleared 510(K)
K
93
2575
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
93
2558
ADULT ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
93
2576
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
1
Cleared 510(K)
K
93
2578
ADULT GAS SAMPLING CIRCUITS
1
Cleared 510(K)
K
93
2497
PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING
1
Cleared 510(K)
K
93
2488
PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITS
1
Cleared 510(K)
K
93
2489
PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR.
1
Cleared 510(K)
K
93
2588
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
1
Cleared 510(K)
K
93
2583
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
93
2486
PMP, LTD. PEDIATRIC TEMPERATURE MONITORING CIRCUIT
1
Cleared 510(K)
K
93
2559
MAPLESON D CIRCUITS
1
Cleared 510(K)
K
93
2587
COAXIAL CIRCUITS
1
Cleared 510(K)
K
93
2586
CUSTOM ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
93
2585
PEDIATRIC ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
93
2582
CUSTOM ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
93
2580
PEDIATRIC ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
93
2579
COAXIAL CIRCUITS
1
Cleared 510(K)
K
93
2490
PMP, LTD. CUSTOM ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
93
2485
PRECISION MED PRODUCTS, LTD. COAXIAL CIRCUITS
1
Cleared 510(K)
K
93
2487
PMP, LTD. PEDIATRIC ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
93
2196
COAXIAL CIRCUITS
1
Cleared 510(K)
K
93
2197
CUSTOM ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
93
2192
PEDIATRIC ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
93
2190
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
1
Cleared 510(K)
K
93
2193
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
1
Cleared 510(K)
K
93
2194
PEDIATRIC GASSAMPLING CIRCUITS
1
Cleared 510(K)
K
93
2195
ADULT GAS SAMPLING CIRCUITS
1
Cleared 510(K)
K
92
6454
ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON
1
Cleared 510(K)
K
92
2789
KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT
1
Cleared 510(K)
K
92
5543
BLD-18000 SERIES HEATED BREATHING CIRCUIT
1
Cleared 510(K)
K
92
4627
XTEND CIRCUITS (TM)
1
Cleared 510(K)
K
92
4889
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
92
5893
OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
93
0252
BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)
1
Cleared 510(K)
K
92
5231
MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS
1
Cleared 510(K)
K
92
5232
MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUIT
1
Cleared 510(K)
K
91
5452
ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
91
1880
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
91
3753
BODAI NEO2 -SAFE AIRWAY PRESSURE CAP
1
Cleared 510(K)
K
91
2504
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED
1
Cleared 510(K)
K
91
2065
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED
1
Cleared 510(K)
K
91
1263
22MM ID/OD ADAPTER
1
Cleared 510(K)
K
91
1736
MEDICAL ASSEMBLIES ADULT ANESTHESIA BREATH CIRCUIT
1
Cleared 510(K)
K
90
5450
ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE
1
Cleared 510(K)
K
91
0896
DISPOSABLE ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
90
4538
MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT
1
Cleared 510(K)
K
90
5148
TEMPERATURE PROBE
1
Cleared 510(K)
K
90
1739
THAYER METERED DOSE INHALER DISPENSER/ADAPTER
1
Cleared 510(K)
K
90
0428
ANESTHESIA BREATHING CIRCUITS
1
Cleared 510(K)
K
90
0594
ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
89
6897
VENTLAB ANESTHESIA CIRCUIT AC 6000
1
Cleared 510(K)
K
89
6365
BABYFLEX HEATED INFANT BREATHING CIRCUIT
1
Cleared 510(K)
K
89
5357
ANETHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
89
3919
ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP
1
Cleared 510(K)
K
89
0499
BIVONA VENTILATOR ISOLATOR SYSTEM
1
Cleared 510(K)
K
89
1479
DISPOSABLE THERMOPLASTIC ANESTH BREATHING CIRCUITS
1
Cleared 510(K)
K
88
4072
15 MILLIMETER MALE AND FEMALE ADAPTERS
1
Cleared 510(K)
K
88
1141
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
88
0683
KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
87
3359
AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE
1
Cleared 510(K)
K
87
0859
BAG-TAIL BLEED VALVE
1
Cleared 510(K)
K
87
1386
BREATHING CIRCUIT
1
Cleared 510(K)
K
87
1669
BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE
1
Cleared 510(K)
K
86
4588
PENLON CIRCLE SYSTEM
1
Cleared 510(K)
K
86
2003
CIRCUIT ANES. BREATHING & COMPONENTS
1
Cleared 510(K)
K
86
1438
CIRCUIT, ANES. BREATHING (NON-REBREATHING)
1
Cleared 510(K)
K
85
4573
ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE
1
Cleared 510(K)
K
85
2632
GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB
1
Cleared 510(K)
K
85
2866
HYDRO-BAC FILTER
1
Cleared 510(K)
K
85
2405
LASERSAFE PERSONNEL AND PATIENT SHIELDS
1
Cleared 510(K)
K
85
3065
#6003 NON CONDUCTIVE ANESTHESIA CIR W/ BREATH BAG
1
Cleared 510(K)
K
85
3342
6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG
1
Cleared 510(K)
K
85
3343
3015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT W
1
Cleared 510(K)
K
85
3344
4000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUIT
1
Cleared 510(K)
K
85
2314
#6010 NON-CONDUCTIVE VENTILATOR CIRCUIT
1
Cleared 510(K)
K
85
2311
#3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
1
Cleared 510(K)
K
85
2316
#3011 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
1
Cleared 510(K)
K
85
2315
#3012 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
1
Cleared 510(K)
K
85
2313
#3001 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
1
Cleared 510(K)
K
85
2312
#3005 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
1
Cleared 510(K)
K
85
1193
ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
85
1531
4013 NON CONDUCTIVE ANESTH. CIRCUIT W/BREATH-BAG
1
Cleared 510(K)
K
85
1530
4003 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREAT\GAS
1
Cleared 510(K)
K
85
1529
4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL
1
Cleared 510(K)
K
84
4149
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
1
Cleared 510(K)
K
84
2492
AMER. MEDICAL PLASTICS CO 20100
1
Cleared 510(K)
K
84
2488
SAMSON 1000 ANESTHESIA CIRCUIT
1
Cleared 510(K)
K
84
1264
BABYSET TM & PAC TM -PULMONARY ASSIST
1
Cleared 510(K)
K
84
1455
REUSEABLE NON-CONDUCTIVE FIXED Y
1
Cleared 510(K)
K
84
0431
SCRATCH & SNIFF FOR ANESTHESIA
1
Cleared 510(K)
K
84
0740
CIRCUIT BREATHING
1
Cleared 510(K)
K
84
0850
ANESTHESIA VENTILATOR CIRCUIT
1
Cleared 510(K)
K
84
0056
PEDIATRIC INTUBATION CIRCUIT
1
Cleared 510(K)
K
83
3871
UNIVERSAL CONTROL ARM
1
Cleared 510(K)
K
83
3478
HUMPHREY A.D.E. SYSTEM
1
Cleared 510(K)
K
83
3196
VOLUME VENTILATOR CIRCUIT-NEBULIZER
1
Cleared 510(K)
K
83
3088
SPIROMETER ISOLATION VALVE #8890
1
Cleared 510(K)
K
83
2453
SLIMB SINGLE LIMB BREATHING CIRCUIT
1
Cleared 510(K)
K
83
0475
BRAIN MODULE RJ-Z10
1
Cleared 510(K)
K
83
0470
ANESTHESIA BREATHING CIRCUITS
1
Cleared 510(K)
K
82
3714
DISPOSABLE NON-REBREATHING ANES. CIRCUIT
1
Cleared 510(K)
K
82
2769
THORATEC GAS SAMPLING CONNECTOR
1
Cleared 510(K)
K
82
2379
DISPOSABLE ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
82
1311
ESPREE' BREATHING CIRCUIT (W/ACCESS
1
Cleared 510(K)
K
82
1087
ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
82
1086
M T M CIRCUIT
1
Cleared 510(K)
K
82
0352
ANALGESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
81
3382
DISPOSABLE ADULT ANES. CIRCUIT
1
Cleared 510(K)
K
81
2624
OXEQUIP CONDUCTIVE & NON ANES. BREATH
1
Cleared 510(K)
K
81
1858
KHI CPRAM BREATHING CIRCUIT
1
Cleared 510(K)
K
81
1700
CIRCUIT, BREATHING
1
Cleared 510(K)
K
81
1413
DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR
1
Cleared 510(K)
K
81
1015
POSITIVE CLOSURE ANESTHETIC VALVE
1
Cleared 510(K)
K
80
1191
ANESTHESIA BREATHING CIRCUITS
1
Cleared 510(K)
K
80
1111
PEDIATRIC ANESTHESIA CIRCUIT
1
Cleared 510(K)
K
80
0498
ADULT ANESTHESIA BREATHING CIRCUITS . .
1
Cleared 510(K)
K
80
0499
PEDIATRIC ANESTHESIA BREATHING CIRCUITS
1
Cleared 510(K)
K
79
2499
AMBU PAEDI ANAESTHESIA SYSTEM
1
Cleared 510(K)
K
79
0214
MODIFIED JACKSON-REES CIRCUIT
1
Cleared 510(K)
K
79
0115
BREATHING CIRCUIT, DISPOSABLE
1
Cleared 510(K)
K
78
1908
BREATHING CIRCUIT PRODUCTS, ANESTHESIA
1
Cleared 510(K)
K
78
0044
BREATHING CIRCUIT, BAIN
1
Cleared 510(K)
K
77
1518
INSPIRATORY FORCE ADAPTOR
1
Cleared 510(K)
K
77
1307
BAIN BREATHING CIRCUIT
1
Cleared 510(K)
K
77
1034
HI-MID CURCUIT
1
Cleared 510(K)
K
77
1134
ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
77
1017
CITADEL CPAP ACCESSORY KIT
1
Cleared 510(K)
K
77
0838
ANESTHESIA BREATHING CIRCUIT, DISPOSABLE
1
Cleared 510(K)
K
77
0549
PEDIATRIC ANESTHESIA CIRCUIT
1
Cleared 510(K)
K
77
0286
VENTILATOR BREATHING CIRCUIT
1
Cleared 510(K)
K
76
0819
CONDUCTIVE ANESTHESIA BREATHING CIRCUIT
1
Cleared 510(K)
K
76
0565
VENTILATOR CIRCUITS
1
Cleared 510(K)
K
76
0149
CONDUCTIVE ANESTHSIA BREATH. CIRCUIT
1
Cleared 510(K)
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
/
CAI
/
K932780
View Source
MALE/MALE LUER TRANSFER TUBING
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K932780
510(k) Type
Traditional
Applicant
INNOVATIONS FOR MECHANICAL VENTILATION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/24/1994
Days to Decision
229 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)
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)
K
95
4480
CONDENSATE COLLECTION KIT
K
95
3787
UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT
K
95
3788
UNICOR, INC. GAS SAMPLING LINES & CONNECTORS
K
95
2020
PRIMA PEDIATRIC ANESTHESIA CIRCUITS
K
95
2019
PRIMA ADULT GAS SAMPLING CIRCUITS
K
95
2014
PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K
95
2018
PRIMA COAXIAL CIRCUITS
K
95
2017
PRIMA MAPLESON D CIRCUIT
K
95
2016
PRIMA PEDIATRIC GAS SAMPLING CIRCUITS
K
95
2009
PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K
94
5565
SPIRO-FLEX
K
93
2288
NEONATAL BREATHING CIRCUIT MODIFICATION
K
94
5984
MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS
K
94
4533
PRIMA, INC. ADULT ANESTHESIA CIRCUIT
K
94
5314
CLEVELAND TUBING, INC. EXPANDABLE/COLLAPSIBLEMEDICAL TUBING
K
94
4429
PRECISION THERMOPLASTIC COMPONENETS, INC. TUBING
K
94
0889
CONNECTORS AND AIRWAY EXTENSIONS
K
94
0890
CORRUGATED TUBING
K
94
4295
KARL STORZ LARYNGOSCOPE ACCESSORIES
K
94
2135
M.A.G. INC. COAXIAL CIRCUITS
K
94
2134
M.A.G. INC. BREALTHING BAGS
K
94
2122
PEDIATRIC ANESTHESIA CIRCUITS
K
94
2123
M.A.G. INC. VENTILATOR HOSES
K
94
2124
GAS SAMPLING LINES AND CONNECTORS CIRCUITS
K
94
2125
VOLUME VENTILATOR
K
94
2126
M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT
K
94
2127
M.A.G INC. PEDIATRIC GAS SAMPLING CIRCUITS
K
94
2128
M.A.G. INC. ADULT GAS SAMPLING CIRCUITS
K
94
2129
M.A.G INC. ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K
94
2130
M.A.G. INC. MAPLESON D CIRCUITS
K
94
2131
M.A.G. INC. GUEDEL AIRWAYS
K
94
2132
M.A.G. INC. HYPERINFLATION SYSTEM
K
94
2133
M.A.G. INC. CUSTOM ANESTHESIA CIRCUITS
K
94
2136
M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K
94
2570
MAPLESON D CIRCUIT
K
94
2568
ADULT ANESTHESIA BREATHING CIRCUIT
K
93
4462
ADULT ANESTHESIA BREATHING CIRCUIT KITS
K
93
5168
ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT KITS
K
93
2781
DUAL VALVED RESPIRATORY T
K
93
2780
MALE/MALE LUER TRANSFER TUBING
K
93
1487
BLD HEATED BREATHING CIRCUIT W/EXHALATION VALVE
K
93
5044
EASYFLOW AIRWAY ADAPTER
K
93
3641
BLD NEONATAL HEATED WIRE BREATHING CIRCUIT- 30 VOLT COMPATIBLE
K
93
0713
THE INFANT FLOW SYSTEM
K
93
2708
PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS
K
93
2707
ADULT ANESTHESIA BREATHING CIRCUIT
K
93
2710
GAS SAMPLING LINES AND CONNECTORS
K
93
2562
GAS SAMPLING LINES AND CONNECTORS
K
93
2590
ADULT GAS SAMPLING CIRCUITS
K
93
2577
PEDIATRIC GAS SAMPLING
K
93
2589
PEDIATRIC GAS SAMPLING CIRCUITS
K
93
2575
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K
93
2558
ADULT ANESTHESIA BREATHING CIRCUIT
K
93
2576
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K
93
2578
ADULT GAS SAMPLING CIRCUITS
K
93
2497
PRECISION MED PRODUCTS, LTD. ADULT GAS SAMPLING
K
93
2488
PMP, LTD. PEDIATRIC GAS SAMPLING CIRCUITS
K
93
2489
PMP, LTD. ADULT TEMP. MONITORING ANESTHESIA CIR.
K
93
2588
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K
93
2583
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K
93
2486
PMP, LTD. PEDIATRIC TEMPERATURE MONITORING CIRCUIT
K
93
2559
MAPLESON D CIRCUITS
K
93
2587
COAXIAL CIRCUITS
K
93
2586
CUSTOM ANESTHESIA CIRCUITS
K
93
2585
PEDIATRIC ANESTHESIA CIRCUITS
K
93
2582
CUSTOM ANESTHESIA CIRCUITS
K
93
2580
PEDIATRIC ANESTHESIA CIRCUITS
K
93
2579
COAXIAL CIRCUITS
K
93
2490
PMP, LTD. CUSTOM ANESTHESIA CIRCUITS
K
93
2485
PRECISION MED PRODUCTS, LTD. COAXIAL CIRCUITS
K
93
2487
PMP, LTD. PEDIATRIC ANESTHESIA CIRCUITS
K
93
2196
COAXIAL CIRCUITS
K
93
2197
CUSTOM ANESTHESIA CIRCUITS
K
93
2192
PEDIATRIC ANESTHESIA CIRCUITS
K
93
2190
ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
K
93
2193
PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K
93
2194
PEDIATRIC GASSAMPLING CIRCUITS
K
93
2195
ADULT GAS SAMPLING CIRCUITS
K
92
6454
ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON
K
92
2789
KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT
K
92
5543
BLD-18000 SERIES HEATED BREATHING CIRCUIT
K
92
4627
XTEND CIRCUITS (TM)
K
92
4889
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT
K
92
5893
OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT
K
93
0252
BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)
K
92
5231
MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS
K
92
5232
MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUIT
K
91
5452
ANESTHESIA BREATHING CIRCUIT
K
91
1880
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT
K
91
3753
BODAI NEO2 -SAFE AIRWAY PRESSURE CAP
K
91
2504
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED
K
91
2065
DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED
K
91
1263
22MM ID/OD ADAPTER
K
91
1736
MEDICAL ASSEMBLIES ADULT ANESTHESIA BREATH CIRCUIT
K
90
5450
ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE
K
91
0896
DISPOSABLE ANESTHESIA BREATHING CIRCUIT
K
90
4538
MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT
K
90
5148
TEMPERATURE PROBE
K
90
1739
THAYER METERED DOSE INHALER DISPENSER/ADAPTER
K
90
0428
ANESTHESIA BREATHING CIRCUITS
K
90
0594
ANESTHESIA BREATHING CIRCUIT
K
89
6897
VENTLAB ANESTHESIA CIRCUIT AC 6000
K
89
6365
BABYFLEX HEATED INFANT BREATHING CIRCUIT
K
89
5357
ANETHESIA BREATHING CIRCUIT
K
89
3919
ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP
K
89
0499
BIVONA VENTILATOR ISOLATOR SYSTEM
K
89
1479
DISPOSABLE THERMOPLASTIC ANESTH BREATHING CIRCUITS
K
88
4072
15 MILLIMETER MALE AND FEMALE ADAPTERS
K
88
1141
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
K
88
0683
KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT
K
87
3359
AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE
K
87
0859
BAG-TAIL BLEED VALVE
K
87
1386
BREATHING CIRCUIT
K
87
1669
BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE
K
86
4588
PENLON CIRCLE SYSTEM
K
86
2003
CIRCUIT ANES. BREATHING & COMPONENTS
K
86
1438
CIRCUIT, ANES. BREATHING (NON-REBREATHING)
K
85
4573
ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE
K
85
2632
GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB
K
85
2866
HYDRO-BAC FILTER
K
85
2405
LASERSAFE PERSONNEL AND PATIENT SHIELDS
K
85
3065
#6003 NON CONDUCTIVE ANESTHESIA CIR W/ BREATH BAG
K
85
3342
6013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAG
K
85
3343
3015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT W
K
85
3344
4000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUIT
K
85
2314
#6010 NON-CONDUCTIVE VENTILATOR CIRCUIT
K
85
2311
#3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K
85
2316
#3011 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K
85
2315
#3012 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K
85
2313
#3001 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K
85
2312
#3005 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K
85
1193
ANESTHESIA BREATHING CIRCUIT
K
85
1531
4013 NON CONDUCTIVE ANESTH. CIRCUIT W/BREATH-BAG
K
85
1530
4003 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREAT\GAS
K
85
1529
4010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIAL
K
84
4149
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
K
84
2492
AMER. MEDICAL PLASTICS CO 20100
K
84
2488
SAMSON 1000 ANESTHESIA CIRCUIT
K
84
1264
BABYSET TM & PAC TM -PULMONARY ASSIST
K
84
1455
REUSEABLE NON-CONDUCTIVE FIXED Y
K
84
0431
SCRATCH & SNIFF FOR ANESTHESIA
K
84
0740
CIRCUIT BREATHING
K
84
0850
ANESTHESIA VENTILATOR CIRCUIT
K
84
0056
PEDIATRIC INTUBATION CIRCUIT
K
83
3871
UNIVERSAL CONTROL ARM
K
83
3478
HUMPHREY A.D.E. SYSTEM
K
83
3196
VOLUME VENTILATOR CIRCUIT-NEBULIZER
K
83
3088
SPIROMETER ISOLATION VALVE #8890
K
83
2453
SLIMB SINGLE LIMB BREATHING CIRCUIT
K
83
0475
BRAIN MODULE RJ-Z10
K
83
0470
ANESTHESIA BREATHING CIRCUITS
K
82
3714
DISPOSABLE NON-REBREATHING ANES. CIRCUIT
K
82
2769
THORATEC GAS SAMPLING CONNECTOR
K
82
2379
DISPOSABLE ANESTHESIA BREATHING CIRCUIT
K
82
1311
ESPREE' BREATHING CIRCUIT (W/ACCESS
K
82
1087
ANESTHESIA BREATHING CIRCUIT
K
82
1086
M T M CIRCUIT
K
82
0352
ANALGESIA BREATHING CIRCUIT
K
81
3382
DISPOSABLE ADULT ANES. CIRCUIT
K
81
2624
OXEQUIP CONDUCTIVE & NON ANES. BREATH
K
81
1858
KHI CPRAM BREATHING CIRCUIT
K
81
1700
CIRCUIT, BREATHING
K
81
1413
DABC NONCONDUCTIVE PEDIAT. ANESTH. CIR
K
81
1015
POSITIVE CLOSURE ANESTHETIC VALVE
K
80
1191
ANESTHESIA BREATHING CIRCUITS
K
80
1111
PEDIATRIC ANESTHESIA CIRCUIT
K
80
0498
ADULT ANESTHESIA BREATHING CIRCUITS . .
K
80
0499
PEDIATRIC ANESTHESIA BREATHING CIRCUITS
K
79
2499
AMBU PAEDI ANAESTHESIA SYSTEM
K
79
0214
MODIFIED JACKSON-REES CIRCUIT
K
79
0115
BREATHING CIRCUIT, DISPOSABLE
K
78
1908
BREATHING CIRCUIT PRODUCTS, ANESTHESIA
K
78
0044
BREATHING CIRCUIT, BAIN
K
77
1518
INSPIRATORY FORCE ADAPTOR
K
77
1307
BAIN BREATHING CIRCUIT
K
77
1034
HI-MID CURCUIT
K
77
1134
ANESTHESIA BREATHING CIRCUIT
K
77
1017
CITADEL CPAP ACCESSORY KIT
K
77
0838
ANESTHESIA BREATHING CIRCUIT, DISPOSABLE
K
77
0549
PEDIATRIC ANESTHESIA CIRCUIT
K
77
0286
VENTILATOR BREATHING CIRCUIT
K
76
0819
CONDUCTIVE ANESTHESIA BREATHING CIRCUIT
K
76
0565
VENTILATOR CIRCUITS
K
76
0149
CONDUCTIVE ANESTHSIA BREATH. CIRCUIT
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
/
CAI
/
K932780
View Source
MALE/MALE LUER TRANSFER TUBING
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K932780
510(k) Type
Traditional
Applicant
INNOVATIONS FOR MECHANICAL VENTILATION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/24/1994
Days to Decision
229 days
Submission Type
Statement