Anesthesiology

CAP · Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Anesthesiology · 21 CFR 868.2600 · Class 2

Overview

Product CodeCAP
Device NameMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
Regulation21 CFR 868.2600
Device ClassClass 2
Review PanelAnesthesiology
3rd-Party ReviewableYes

Identification

An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

Classification Rationale

Class II (performance standards).

Cleared Devices (78)

RecordDevice NameApplicantDecision DateDecision
K201666SINGLE USE MANOMETERFlexicare Medical Limited.Nov 13, 2020SESE
K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.Sep 18, 2019SESE
K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.May 1, 2019SESE
K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCFeb 9, 2018SESE
K153733VORTRAN ManometerVortran Medical Technology 1, Inc.Sep 16, 2016SESE
K143148Disposable Pressure Manometer (DPM)Westmed, Inc.Aug 11, 2015SESE
K140370DISPOSABLE PRESSURE MANOMETERBesmed Health Business CorpJun 19, 2014SESE
K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.Aug 22, 2013SESE
K122077MANOMETERIntersurgical, Inc.Jan 10, 2013SESE
K120118VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETERVentlab Corp.May 24, 2012SESE
K103639VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRICVortran Medical Technology 1, Inc.Sep 15, 2011SESE
K110119PRESSURE MANOMETERNeoforce Group, Inc.Jun 10, 2011SESE
K102377VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0A Plus MedicalNov 18, 2010SESE
K081778NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORSInstrumentation Industries, Inc.Sep 12, 2008SESE
K050309PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000Viasys MedsystemsMar 25, 2005SESE
K040991AMBU DISPOSABLE PRESSURE MANOMETERAmbu, Inc.Jul 22, 2004SESE
K022402DISPOSABLE PRESSURE MANOMETERVital Signs, Inc.Aug 22, 2002SESE
K003497DISPOSABLE PRESSURE MONITOREngineered Medical SystemsNov 30, 2000SESE
K000959CRITERION 60 OR PM 60Caradyne, Ltd.Jun 22, 2000SESE
K992101CRITERION 40 OR PM 40Caradyne, Ltd.Jan 6, 2000SESE
K973347TSX PRM PULMONARY RESUSCITATION MONITORSpiracle TechnologyJul 23, 1998SESE
K9613181ST RESPONSE DISPOSABLE MANOMETERIntertech Resources, Inc.Dec 17, 1996SESE
K954486MERCURY AIRWAY PRESSURE MANOMETERMercury MedicalApr 25, 1996SESE
K936009AMS 3000MAcutronic Medical Systems AGMay 3, 1995SESE
K943146PORTA-RESP MONITORS & M Instrument Co.Nov 28, 1994SESE
K940375MICRO MPMMicro Direct, Inc.Nov 21, 1994SESE
K931394CM5000R REMOTE INDICATORCanadian Monaghan , Ltd.Jul 1, 1993SESE
K931287CM7000 REMOTE INDICATORCanadian Monaghan , Ltd.Jul 1, 1993SESE
K925673AIRWAY PRESSURE MONITOR CM 5000 NGANCanadian Monaghan , Ltd.Jun 9, 1993SESE
K921978BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGECore-M, Inc.Nov 17, 1992SESE
K904935RESPIRONICS' DIGITAL MANOMETERRespironics, Inc.Apr 3, 1991SESE
K902381PENLON BREATHING SYSTEM PRESSURE MONITORPenlon, Inc.Aug 17, 1990SESE
K902276RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)Respironics, Inc.Aug 17, 1990SESE
K896136INFANT C.P.A.P. MONITORHudson Oxygen Therapy Sales Co.Jan 9, 1990SESE
K895747VENTILARM II PORTABLE AIRWAY PRESSURE MONITORHudson Oxygen Therapy Sales Co.Oct 27, 1989SESE
K894361LIFECARE PRESSURE ALARM CAT. NO. 34-010Lifecare Services, Inc.Oct 5, 1989SESE
K894689PENLON IDP PRESSURE FAILURE ALARMPenlon, Inc.Aug 10, 1989SESE
K892942BREATH TRACKERCore-M, Inc.Jun 23, 1989SESE
K890010CM 7000MRTrudell MedicalJun 12, 1989SESE
K873953CM 5000R REMOTE AIRWAY PRESSURECanadian Monaghan , Ltd.Oct 27, 1987SESE
K871336M-1 PRESSURE MONITORBio-Med Devices, Inc.Jun 5, 1987SESE
K871139M-10 VENTILATION MONITORBio-Med Devices, Inc.Apr 21, 1987SESE
K871083CM 5000 MONITOR AIRWAY PRESSURECanadian Monaghan , Ltd.Apr 8, 1987SESE
K864536OHMEDA 5500 AIRWAY PRESSURE MONITOROhmeda MedicalJan 12, 1987SESE
K861720MODIFIED BAROMED BREATHING PRESSURE MONITORDraeger Medical, Inc.May 9, 1986SESE
K861330SECHRIST AIRWAY PRESSURE MONITOR MODEL 600Sechrist Industries, Inc.Apr 11, 1986SESE
K854934VENTILATOR PRESSURE ALARM MODEL VPA-100Respiratory Support Products, Inc.Dec 24, 1985SESE
K852826AN PRESSURE MONITORFerguson MedicalDec 3, 1985SESE
K852824PMA PRESSURE MONITORFerguson MedicalDec 3, 1985SESE
K851905LPA-2 REMOTE ALARMLife Products, Inc.Jul 8, 1985SESE
K840420AIRWAY PRESSURE MONITORRespiratory Support Products, Inc.Apr 5, 1984SESE
K840279DRAGER BAROMEDDraeger Medical, Inc.Mar 2, 1984SESE
K832271EMERSON MODEL 3MV-AP AND 3V-AP PRESS-J. H. Emerson Co.Sep 12, 1983SESE
K821649MONAGHAN'S PRESSURE ALARMMonaghan Medical Corp.Aug 5, 1982SESE
K821667SINGLE USE NON-CONDUCTIVE CIRC. DISCONVital Signs, Inc.Jun 24, 1982SESE
K820720RESPIRATOR MONITORRv SystemsApr 26, 1982SESE
K820353MONITRON MODEL JL-7Florida Medical Equipment Repair, Inc.Mar 12, 1982SESE
K812960EAST VENTILARM PRESSURE MONITOR ALARM S.Cairco , Ltd.Nov 16, 1981SESE
K812041VENTI-MONITOR MODEL 101Medix Medical Electronics (U.S.A.), Inc.Sep 25, 1981SESE
K812140BIRD MEAN AIRWAY PRESSURE MONITOR3M CompanyAug 20, 1981SESE
K810753AIRWAY PRESSURE MONITORImpact Instrumentation, Inc.Mar 31, 1981SESE
K810648SECHRIST AIRWAY PRESSURE MONITOR #400Sechrist Industries, Inc.Mar 20, 1981SESE
K810547BLSI VENTILATION MONITORBunnell Life Systems, Inc.Mar 11, 1981SESE
K810255MEAN PRESSURE MONITORHealthdyne, Inc.Feb 12, 1981SESE
K802955MONITOR, AIRWAY PRESSURENovametrix Medical Systems, Inc.Dec 19, 1980SESE
K802054TRAVENOL ULTRASONIC NEBULIZER CUPSTravenol Laboratories, S.A.Dec 1, 1980SESE
K8025653MP-7 SCANNER RESPIRATORY MONITORBird Products Corp.Oct 31, 1980SESE
K802090DRAGER PRESSURE MONITOR, SELF-DIAGNOSTICDraeger Medical, Inc.Sep 26, 1980SESE
K801254PENLON I.D.P. PRESSSURE FAILURE ALARMPenlon, Inc.Jun 9, 1980SESE
K792516RESPIRATOR DISCONNECT ALARM CR 201Intersect Medical Products, Inc.Jan 9, 1980SESE
K792515RESPIRATOR DISCONNECT ALARMIntersect Medical Products, Inc.Jan 9, 1980SESE
K791561RESPIRATOR DISCONNECT ALARM VA-100Intersect Medical Products, Inc.Sep 19, 1979SESE
K791527RESPIRATOR DISCONNECT ALARM CR201Intersect Medical Products, Inc.Sep 19, 1979SESE
K790370BUNN MODEL #40 LOW PRESSURE ALARMThe John Bunn Co.Mar 28, 1979SESE
K782174PRESSURE ALARMThompson Respiration Products, Inc.Jan 22, 1979SESE
K781714PNEUMOGARD MODEL 1230Novametrix Medical Systems, Inc.Nov 27, 1978SESE
K781697PRESSURE, LOW/HIGH MODEL C1070Timeter Instrument Corp.Oct 27, 1978SESE
K780863MODEL 65 HIGH & LOW PRESSURE ALARMThe John Bunn Co.Aug 21, 1978SESE

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