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
K
22
1634
Oxymag - Transport and Emergency Ventilator
2
Cleared 510(K)
K
20
2219
VORTRAN GO2VENT with PEEP Valve
2
Cleared 510(K)
K
19
3191
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
2
Cleared 510(K)
K
18
2956
Puffin Lite Infant Resuscitation System
2
Cleared 510(K)
K
17
3373
SafeT T-Piece Resuscitator
2
Cleared 510(K)
K
16
1420
MOVES SLC
2
Cleared 510(K)
K
16
2968
VORTRAN GO2VENT
2
Cleared 510(K)
K
14
1595
O-TWO E700,O-TWO E600,O-TWO E500
2
Cleared 510(K)
K
14
2096
T-PIECE RESUSCITATOR
2
Cleared 510(K)
K
14
0049
MOVES SLC
2
Cleared 510(K)
K
14
0707
LIFEBORNE INFANT RESUSCITATOR
2
Cleared 510(K)
K
13
1098
EMERGENCY PORTABLE VENTILATOR
2
Cleared 510(K)
K
13
2021
AHP 300, EMERGENCY PORTABLE VENTILATOR
2
Cleared 510(K)
K
13
2759
VENTRAIN
2
Cleared 510(K)
K
13
1877
SAVE II, SAVE II BASIC
2
Cleared 510(K)
K
12
3957
PNEUPAC PARAPAC PLUS
2
Cleared 510(K)
K
11
2783
MANUJET III
2
Cleared 510(K)
K
10
2542
RESUSCI FLOW; RESUSCI FLOW 104
2
Cleared 510(K)
K
09
3862
CAREVENT HANDHELD CPAP SYSTEM
2
Cleared 510(K)
K
09
3913
MERCURY MEDICAL T-PIECE RESUSCITATOR
2
Cleared 510(K)
K
09
3261
MOVES
2
Cleared 510(K)
K
09
2085
ISPIRA RESUSCITATION UNIT
2
Cleared 510(K)
K
09
0356
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
2
Cleared 510(K)
K
08
3507
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
2
Cleared 510(K)
K
08
3385
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
2
Cleared 510(K)
K
08
1330
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
2
Cleared 510(K)
K
08
0063
MASS CASUALTY VENTILATOR, MODEL MCV100
2
Cleared 510(K)
K
08
0692
MACS CPAP SYSTEM
2
Cleared 510(K)
K
07
3261
VAR MONITOR
2
Cleared 510(K)
K
07
2214
PORTABLE VENTILATOR, MODEL EPV-100
2
Cleared 510(K)
K
07
1527
PNEUPAC VR1 AIR MIX
2
Cleared 510(K)
K
07
1221
SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
2
Cleared 510(K)
K
07
0636
AUTOVENT 4000 WITH CPAP
2
Cleared 510(K)
K
07
0120
AUTOVENT MODEL 4000
2
Cleared 510(K)
K
07
0210
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
2
Cleared 510(K)
K
05
1476
UNI-VENT MODEL 73X
2
Cleared 510(K)
K
05
1469
CAREVENT ATV+ AND CAREVENT MRI
2
Cleared 510(K)
K
05
1889
CAREVENT CA AND DRA
2
Cleared 510(K)
K
05
1322
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
2
Cleared 510(K)
K
04
3495
BABYPAC
2
Cleared 510(K)
K
04
1473
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
2
Cleared 510(K)
K
04
0090
COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)
2
Cleared 510(K)
K
03
2386
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
2
Cleared 510(K)
K
03
0803
PARAPAC 200D TRANSPORT, MODEL V200D
2
Cleared 510(K)
K
02
1841
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
2
Cleared 510(K)
K
02
0899
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
2
Cleared 510(K)
K
02
1520
EMT-CPAP
2
Cleared 510(K)
K
00
1430
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
2
Cleared 510(K)
K
99
1785
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
2
Cleared 510(K)
K
99
1195
CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
2
Cleared 510(K)
K
98
3857
AUTOVENT 1500
2
Cleared 510(K)
K
98
3785
AUTOVENT 1000
2
Cleared 510(K)
K
98
3705
EMT RESUSCITATOR
2
Cleared 510(K)
K
98
3643
GENESIS BLS
2
Cleared 510(K)
K
98
2225
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
2
Cleared 510(K)
K
97
3975
RESPIRTECHPRO
2
Cleared 510(K)
K
96
0515
PARAPAC
2
Cleared 510(K)
K
94
4349
OXYLATOR EM-100
2
Cleared 510(K)
K
95
1126
DRAGER MEDICAL AIR COMPRESSOR
2
Cleared 510(K)
K
94
4397
BNOS MICROVENT, MODEL AC AND MODEL AO
2
Cleared 510(K)
K
94
1870
LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
2
Cleared 510(K)
K
94
1871
LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100
2
Cleared 510(K)
K
93
1473
IMPACT MODEL 753
2
Cleared 510(K)
K
92
4272
MEDIRESP III
2
Cleared 510(K)
K
93
2200
LSPI AUTOMATIC VENTILATOR
2
Cleared 510(K)
K
93
2199
LSPI AUTOMATIC VENTILATOR, MODEL AV3000
2
Cleared 510(K)
K
93
2170
FLYNNR GENESIS II A/C, A/O AND IDLH
2
Cleared 510(K)
K
92
0910
OXYGEN POWERED RESUSCITATOR FOR CPR
2
Cleared 510(K)
K
92
1926
JET VENTILATOR/JETTING DEVICE
2
Cleared 510(K)
K
91
3039
FLLYNN(R) GENESIS AC
2
Cleared 510(K)
K
91
5564
SPIROS
2
Cleared 510(K)
K
91
0699
LIFE-02 (NON-REFILLABLE CYLINDER)
2
Cleared 510(K)
K
91
0435
LIFE OXYGENPAC 6/12 LPM
2
Cleared 510(K)
K
91
0434
LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL
2
Cleared 510(K)
K
91
1261
ERA 2000A
2
Cleared 510(K)
K
90
4920
AMBU MATIC AUTOMATIC RESUSCITATOR
2
Cleared 510(K)
K
91
0201
LIFE O2
2
Cleared 510(K)
K
90
5697
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
2
Cleared 510(K)
K
90
1846
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
2
Cleared 510(K)
K
89
5946
BIVONA CARDEN INTERMITTENT JETTING DEVICE
2
Cleared 510(K)
K
89
2885
RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR
2
Cleared 510(K)
K
88
4089
ERA 2000 EMERGENCY RESUSCITATOR
2
Cleared 510(K)
K
88
2833
THE BERG RESUSCITATION APPARATUS
2
Cleared 510(K)
K
87
0424
LSP AUTOMATIC VENTILATOR, MODEL 456
2
Cleared 510(K)
K
87
4656
AUTOMATIC VENTILATOR AV2000
2
Cleared 510(K)
K
86
3410
PATIENT VALVE WITH AIR ENTRAINMENT
2
Cleared 510(K)
K
86
2830
MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR
2
Cleared 510(K)
K
86
2192
RESUSCITATOR MODELS 10400/10500/10600/10700/10800
2
Cleared 510(K)
K
86
1272
IMPACT MODELS 701, 702 AND 703
2
Cleared 510(K)
K
86
0077
SG-066 OXYGEN ENRICHMENT KIT
2
Cleared 510(K)
K
85
5092
LIFE CORP. OXYGEN PAC
2
Cleared 510(K)
K
85
3971
REGULATOR-INHALATOR SYSTEM
2
Cleared 510(K)
K
85
1337
502 RESUSCITATORY INHALATOR VALVE
2
Cleared 510(K)
K
84
1893
MAXAMAN
2
Cleared 510(K)
K
83
0404
RAD VALVE
2
Cleared 510(K)
K
80
0456
EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR.
2
Cleared 510(K)
K
79
2453
PNEUPAC OXYGEN THERAPY UNIT
2
Cleared 510(K)
K
78
0168
PARAMEDIC O2 KIT
2
Cleared 510(K)
K
77
1299
EMERGENCY OXYGEN RESUSCITATOR
2
Cleared 510(K)
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
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
/
BTL
/
K083385
View Source
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083385
510(k) Type
Traditional
Applicant
ALLIED HEALTHCARE PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/14/2009
Days to Decision
178 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)
K
22
1634
Oxymag - Transport and Emergency Ventilator
K
20
2219
VORTRAN GO2VENT with PEEP Valve
K
19
3191
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
K
18
2956
Puffin Lite Infant Resuscitation System
K
17
3373
SafeT T-Piece Resuscitator
K
16
1420
MOVES SLC
K
16
2968
VORTRAN GO2VENT
K
14
1595
O-TWO E700,O-TWO E600,O-TWO E500
K
14
2096
T-PIECE RESUSCITATOR
K
14
0049
MOVES SLC
K
14
0707
LIFEBORNE INFANT RESUSCITATOR
K
13
1098
EMERGENCY PORTABLE VENTILATOR
K
13
2021
AHP 300, EMERGENCY PORTABLE VENTILATOR
K
13
2759
VENTRAIN
K
13
1877
SAVE II, SAVE II BASIC
K
12
3957
PNEUPAC PARAPAC PLUS
K
11
2783
MANUJET III
K
10
2542
RESUSCI FLOW; RESUSCI FLOW 104
K
09
3862
CAREVENT HANDHELD CPAP SYSTEM
K
09
3913
MERCURY MEDICAL T-PIECE RESUSCITATOR
K
09
3261
MOVES
K
09
2085
ISPIRA RESUSCITATION UNIT
K
09
0356
EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
K
08
3507
BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
K
08
3385
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
K
08
1330
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
K
08
0063
MASS CASUALTY VENTILATOR, MODEL MCV100
K
08
0692
MACS CPAP SYSTEM
K
07
3261
VAR MONITOR
K
07
2214
PORTABLE VENTILATOR, MODEL EPV-100
K
07
1527
PNEUPAC VR1 AIR MIX
K
07
1221
SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12
K
07
0636
AUTOVENT 4000 WITH CPAP
K
07
0120
AUTOVENT MODEL 4000
K
07
0210
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
K
05
1476
UNI-VENT MODEL 73X
K
05
1469
CAREVENT ATV+ AND CAREVENT MRI
K
05
1889
CAREVENT CA AND DRA
K
05
1322
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
K
04
3495
BABYPAC
K
04
1473
VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
K
04
0090
COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)
K
03
2386
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
K
03
0803
PARAPAC 200D TRANSPORT, MODEL V200D
K
02
1841
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
K
02
0899
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
K
02
1520
EMT-CPAP
K
00
1430
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
K
99
1785
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
K
99
1195
CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
K
98
3857
AUTOVENT 1500
K
98
3785
AUTOVENT 1000
K
98
3705
EMT RESUSCITATOR
K
98
3643
GENESIS BLS
K
98
2225
SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
K
97
3975
RESPIRTECHPRO
K
96
0515
PARAPAC
K
94
4349
OXYLATOR EM-100
K
95
1126
DRAGER MEDICAL AIR COMPRESSOR
K
94
4397
BNOS MICROVENT, MODEL AC AND MODEL AO
K
94
1870
LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
K
94
1871
LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100
K
93
1473
IMPACT MODEL 753
K
92
4272
MEDIRESP III
K
93
2200
LSPI AUTOMATIC VENTILATOR
K
93
2199
LSPI AUTOMATIC VENTILATOR, MODEL AV3000
K
93
2170
FLYNNR GENESIS II A/C, A/O AND IDLH
K
92
0910
OXYGEN POWERED RESUSCITATOR FOR CPR
K
92
1926
JET VENTILATOR/JETTING DEVICE
K
91
3039
FLLYNN(R) GENESIS AC
K
91
5564
SPIROS
K
91
0699
LIFE-02 (NON-REFILLABLE CYLINDER)
K
91
0435
LIFE OXYGENPAC 6/12 LPM
K
91
0434
LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL
K
91
1261
ERA 2000A
K
90
4920
AMBU MATIC AUTOMATIC RESUSCITATOR
K
91
0201
LIFE O2
K
90
5697
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
K
90
1846
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
K
89
5946
BIVONA CARDEN INTERMITTENT JETTING DEVICE
K
89
2885
RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR
K
88
4089
ERA 2000 EMERGENCY RESUSCITATOR
K
88
2833
THE BERG RESUSCITATION APPARATUS
K
87
0424
LSP AUTOMATIC VENTILATOR, MODEL 456
K
87
4656
AUTOMATIC VENTILATOR AV2000
K
86
3410
PATIENT VALVE WITH AIR ENTRAINMENT
K
86
2830
MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR
K
86
2192
RESUSCITATOR MODELS 10400/10500/10600/10700/10800
K
86
1272
IMPACT MODELS 701, 702 AND 703
K
86
0077
SG-066 OXYGEN ENRICHMENT KIT
K
85
5092
LIFE CORP. OXYGEN PAC
K
85
3971
REGULATOR-INHALATOR SYSTEM
K
85
1337
502 RESUSCITATORY INHALATOR VALVE
K
84
1893
MAXAMAN
K
83
0404
RAD VALVE
K
80
0456
EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR.
K
79
2453
PNEUPAC OXYGEN THERAPY UNIT
K
78
0168
PARAMEDIC O2 KIT
K
77
1299
EMERGENCY OXYGEN 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)
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
/
BTL
/
K083385
View Source
MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083385
510(k) Type
Traditional
Applicant
ALLIED HEALTHCARE PRODUCTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/14/2009
Days to Decision
178 days
Submission Type
Statement