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
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
K
24
1366
QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
2
Cleared 510(K)
K
23
4053
F&P Optiflow Flow Diverter
2
Cleared 510(K)
K
21
0992
Altech® Exhalation Valve (Single Limb and Dual Limb)
2
Cleared 510(K)
K
19
2285
CPR Face Shield
2
Cleared 510(K)
K
17
3770
OJR215 Pressure Relief Manifold
2
Cleared 510(K)
K
17
1961
Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
2
Cleared 510(K)
K
15
2521
Seal Rite Non-Rebreathing Valve
2
Cleared 510(K)
K
14
2764
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
2
Cleared 510(K)
K
14
2402
BigEasy Non-Rebreathing Valve
2
Cleared 510(K)
K
13
2143
EXHALATION VALVE
2
Cleared 510(K)
K
11
2126
GENUINE FIRST AID CPR MASK
2
Cleared 510(K)
K
11
1191
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
2
Cleared 510(K)
K
10
2299
CPR FACE MASK
2
Cleared 510(K)
K
08
3418
CPR MASK
2
Cleared 510(K)
K
09
1538
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100
2
Cleared 510(K)
K
08
2345
OXYGEN DEMAND VALVE
2
Cleared 510(K)
K
08
1516
MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
2
Cleared 510(K)
K
05
2458
LIV MEDICA CPR FACE MASK
2
Cleared 510(K)
K
05
2743
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
2
Cleared 510(K)
K
04
2727
POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
2
Cleared 510(K)
K
03
1397
MERLIN E-MASK
2
Cleared 510(K)
K
03
1431
BAWMED RESCUE MASK
2
Cleared 510(K)
K
04
0366
PRESSURE MANIFOLD, MODEL BC 110
2
Cleared 510(K)
K
03
0943
MODIFICATION TO HIOX
2
Cleared 510(K)
K
02
3805
LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050
2
Cleared 510(K)
K
02
0665
HI-OX
2
Cleared 510(K)
K
01
0191
Y2000 POCKET RESCUE
2
Cleared 510(K)
K
00
1742
RESUSCI INFLATE-A-SHIELD CPR BARRIER
2
Cleared 510(K)
K
99
3528
RUSCH EMERGENCY MASK
2
Cleared 510(K)
K
99
1617
FACE-2-FACE CPR PROTECTION SHIELD
2
Cleared 510(K)
K
98
3631
AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
2
Cleared 510(K)
K
98
3919
EMS MOUTH TO MASK RESUSCITATORS
2
Cleared 510(K)
K
98
4481
EXHALATION VALVE
2
Cleared 510(K)
K
98
0725
EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
2
Cleared 510(K)
K
98
0052
RESPAIDE
2
Cleared 510(K)
K
98
1169
RONDEX CPR ISO-SHIELD
2
Cleared 510(K)
K
97
3066
NON-REBREATHING 'T' (BE 117)
2
Cleared 510(K)
K
97
0780
ONE-WAY VALVE (WITH CONNECTOR)
2
Cleared 510(K)
K
96
0587
CPROTECTOR 2000
2
Cleared 510(K)
K
96
3755
SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
2
Cleared 510(K)
K
96
0995
CPR BIO-BARRIER FACESHEILD
2
Cleared 510(K)
K
95
5520
RESCUE BREATHER
2
Cleared 510(K)
K
95
4426
CPR LIFE MASK COMPACT BARRIER
2
Cleared 510(K)
K
95
5634
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
2
Cleared 510(K)
K
95
3414
CPR MICROMASK WITH OXYGEN INLET
2
Cleared 510(K)
K
95
3349
SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE
2
Cleared 510(K)
K
95
3230
CPR SUPER POCKET PACK
2
Cleared 510(K)
K
95
3461
CPR MASK & RELATED FAMILY KITS
2
Cleared 510(K)
K
95
1483
CPR MICROMASK
2
Cleared 510(K)
K
94
0820
PERSHIELD CPR DEVICE
2
Cleared 510(K)
K
94
6225
3M FILTRETE(TM) AIR FILTER MEDIA
2
Cleared 510(K)
K
94
0503
MOUTH-TO-MASK RESUSCITATOR
2
Cleared 510(K)
K
95
0770
CPR MICROSHIELD II
2
Cleared 510(K)
K
95
0769
CPR MICROMASK PLUS CATALOG NO 73-402
2
Cleared 510(K)
K
94
5822
CAPNO-FLO(TM) REGULATOR
2
Cleared 510(K)
K
95
0392
4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050
2
Cleared 510(K)
K
94
0712
PPM III
2
Cleared 510(K)
K
94
3761
NON-BREATHING VALVE
2
Cleared 510(K)
K
94
1008
COMPLETE CPR KIT
2
Cleared 510(K)
K
94
5177
4-O2 JR. (CPR MOUTH BARRIER)
2
Cleared 510(K)
K
94
3402
K.P.R. (KING PERSONAL RESUSCITATOR)
2
Cleared 510(K)
K
94
2021
MOUTH TO MOUTH BREATHER
2
Cleared 510(K)
K
93
3756
MAGNASHIELD CPR MOUTH BARRIER
2
Cleared 510(K)
K
91
3163
NON REBREATHING VALVE
2
Cleared 510(K)
K
91
4195
RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED
2
Cleared 510(K)
K
90
2299
CPR VALVE (NON-REBREATHING) MODEL #9030
2
Cleared 510(K)
K
89
1124
NON-REBREATHING AIRWAY AND MASK(S) KITS
2
Cleared 510(K)
K
88
4543
LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK
2
Cleared 510(K)
K
88
3383
LIFEGUARD VENT MASK
2
Cleared 510(K)
K
88
3988
NON-REBREATHING TEE PIECE (NRTP)
2
Cleared 510(K)
K
88
1931
RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR
2
Cleared 510(K)
K
88
2204
RESUSCITATOR VALVE ASSEMBLY W/FILTER
2
Cleared 510(K)
K
87
3570
LIFECARE EXHALATION VALVE #06-699
2
Cleared 510(K)
K
87
1367
HY-FLOW NON-REBREATHING VALVE ASSEMBLY
2
Cleared 510(K)
K
86
4681
CARHILL ONE-WAY RESUSCITATION VALVE
2
Cleared 510(K)
K
87
0895
NO. 1552, VALVED VENTI-COMP
2
Cleared 510(K)
K
87
0382
DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011
2
Cleared 510(K)
K
87
0253
INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR
2
Cleared 510(K)
K
87
0138
1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE
2
Cleared 510(K)
K
86
4472
PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK
2
Cleared 510(K)
K
86
1401
LAERDAL POCKET MASK
2
Cleared 510(K)
K
85
5218
RONDEX CPR VALVE
2
Cleared 510(K)
K
83
3748
RESCUE VALVE
2
Cleared 510(K)
K
83
2868
RESUSCITATION VALVE
2
Cleared 510(K)
K
83
1246
WHISTLER IN-LINE PRESSURE RELEASE VALVE
2
Cleared 510(K)
K
81
0348
CM 3
2
Cleared 510(K)
K
79
1908
RETARD VALVE 3-STACK #M-514
2
Cleared 510(K)
K
79
1907
RETARD VALVE 3-STACK #M-515
2
Cleared 510(K)
K
79
1849
ONE-WAY VALVE-MALE, M-504
2
Cleared 510(K)
K
79
1850
ONE-WAY VALVE-FEMALE, M-503
2
Cleared 510(K)
K
79
0820
NON-REBREATHING T PIECE
2
Cleared 510(K)
K
79
0151
ONE-WAY VALVE
2
Cleared 510(K)
K
78
1920
VALVE, VENT-AWAY TWO-WAY
2
Cleared 510(K)
K
77
0629
VALVE, EXHALATION BE 115-4, 115-5
2
Cleared 510(K)
K
77
0627
ADAPTER, VALVE, ONE WAY BE-130-22
2
Cleared 510(K)
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
/
CBP
/
K042727
View Source
POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042727
510(k) Type
Traditional
Applicant
FOREMOUNT ENT. CO., LTD.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
3/18/2005
Days to Decision
168 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)
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
K
24
1366
QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
K
23
4053
F&P Optiflow Flow Diverter
K
21
0992
Altech® Exhalation Valve (Single Limb and Dual Limb)
K
19
2285
CPR Face Shield
K
17
3770
OJR215 Pressure Relief Manifold
K
17
1961
Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
K
15
2521
Seal Rite Non-Rebreathing Valve
K
14
2764
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
K
14
2402
BigEasy Non-Rebreathing Valve
K
13
2143
EXHALATION VALVE
K
11
2126
GENUINE FIRST AID CPR MASK
K
11
1191
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
K
10
2299
CPR FACE MASK
K
08
3418
CPR MASK
K
09
1538
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100
K
08
2345
OXYGEN DEMAND VALVE
K
08
1516
MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
K
05
2458
LIV MEDICA CPR FACE MASK
K
05
2743
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
K
04
2727
POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
K
03
1397
MERLIN E-MASK
K
03
1431
BAWMED RESCUE MASK
K
04
0366
PRESSURE MANIFOLD, MODEL BC 110
K
03
0943
MODIFICATION TO HIOX
K
02
3805
LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050
K
02
0665
HI-OX
K
01
0191
Y2000 POCKET RESCUE
K
00
1742
RESUSCI INFLATE-A-SHIELD CPR BARRIER
K
99
3528
RUSCH EMERGENCY MASK
K
99
1617
FACE-2-FACE CPR PROTECTION SHIELD
K
98
3631
AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
K
98
3919
EMS MOUTH TO MASK RESUSCITATORS
K
98
4481
EXHALATION VALVE
K
98
0725
EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
K
98
0052
RESPAIDE
K
98
1169
RONDEX CPR ISO-SHIELD
K
97
3066
NON-REBREATHING 'T' (BE 117)
K
97
0780
ONE-WAY VALVE (WITH CONNECTOR)
K
96
0587
CPROTECTOR 2000
K
96
3755
SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
K
96
0995
CPR BIO-BARRIER FACESHEILD
K
95
5520
RESCUE BREATHER
K
95
4426
CPR LIFE MASK COMPACT BARRIER
K
95
5634
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K
95
3414
CPR MICROMASK WITH OXYGEN INLET
K
95
3349
SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE
K
95
3230
CPR SUPER POCKET PACK
K
95
3461
CPR MASK & RELATED FAMILY KITS
K
95
1483
CPR MICROMASK
K
94
0820
PERSHIELD CPR DEVICE
K
94
6225
3M FILTRETE(TM) AIR FILTER MEDIA
K
94
0503
MOUTH-TO-MASK RESUSCITATOR
K
95
0770
CPR MICROSHIELD II
K
95
0769
CPR MICROMASK PLUS CATALOG NO 73-402
K
94
5822
CAPNO-FLO(TM) REGULATOR
K
95
0392
4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050
K
94
0712
PPM III
K
94
3761
NON-BREATHING VALVE
K
94
1008
COMPLETE CPR KIT
K
94
5177
4-O2 JR. (CPR MOUTH BARRIER)
K
94
3402
K.P.R. (KING PERSONAL RESUSCITATOR)
K
94
2021
MOUTH TO MOUTH BREATHER
K
93
3756
MAGNASHIELD CPR MOUTH BARRIER
K
91
3163
NON REBREATHING VALVE
K
91
4195
RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED
K
90
2299
CPR VALVE (NON-REBREATHING) MODEL #9030
K
89
1124
NON-REBREATHING AIRWAY AND MASK(S) KITS
K
88
4543
LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK
K
88
3383
LIFEGUARD VENT MASK
K
88
3988
NON-REBREATHING TEE PIECE (NRTP)
K
88
1931
RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR
K
88
2204
RESUSCITATOR VALVE ASSEMBLY W/FILTER
K
87
3570
LIFECARE EXHALATION VALVE #06-699
K
87
1367
HY-FLOW NON-REBREATHING VALVE ASSEMBLY
K
86
4681
CARHILL ONE-WAY RESUSCITATION VALVE
K
87
0895
NO. 1552, VALVED VENTI-COMP
K
87
0382
DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011
K
87
0253
INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR
K
87
0138
1160 SIMPLE ISOLATION VALVE & 1161 FILTERED VALVE
K
86
4472
PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK
K
86
1401
LAERDAL POCKET MASK
K
85
5218
RONDEX CPR VALVE
K
83
3748
RESCUE VALVE
K
83
2868
RESUSCITATION VALVE
K
83
1246
WHISTLER IN-LINE PRESSURE RELEASE VALVE
K
81
0348
CM 3
K
79
1908
RETARD VALVE 3-STACK #M-514
K
79
1907
RETARD VALVE 3-STACK #M-515
K
79
1849
ONE-WAY VALVE-MALE, M-504
K
79
1850
ONE-WAY VALVE-FEMALE, M-503
K
79
0820
NON-REBREATHING T PIECE
K
79
0151
ONE-WAY VALVE
K
78
1920
VALVE, VENT-AWAY TWO-WAY
K
77
0629
VALVE, EXHALATION BE 115-4, 115-5
K
77
0627
ADAPTER, VALVE, ONE WAY BE-130-22
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
/
CBP
/
K042727
View Source
POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042727
510(k) Type
Traditional
Applicant
FOREMOUNT ENT. CO., LTD.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
3/18/2005
Days to Decision
168 days
Submission Type
Summary