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CAP — Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Class II

FDA Device Classification

Classification Details

Product Code
CAP
Device Class
Class II
Regulation Number
868.2600
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201666flexicare medical limitedSINGLE USE MANOMETERNovember 13, 2020
K182292vortran medical technology 1VORTRAN APM-PlusSeptember 18, 2019
K180510instrumentation industriesNS 120P-TRS Airway Pressure GaugeMay 1, 2019
K172284drw medicalNAPA LP-15 Airway Pressure MonitorFebruary 9, 2018
K153733vortran medical technology 1VORTRAN ManometerSeptember 16, 2016
K143148westmedDisposable Pressure Manometer (DPM)August 11, 2015
K140370besmed health businessDISPOSABLE PRESSURE MANOMETERJune 19, 2014
K122627galemedGIO DIGITAL PRESSURE GUAGESAugust 22, 2013
K122077intersurgicalMANOMETERJanuary 10, 2013
K120118ventlabVENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETERMay 24, 2012
K103639vortran medical technology 1VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VSeptember 15, 2011
K110119neoforce groupPRESSURE MANOMETERJune 10, 2011
K102377a plus medicalVENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 November 18, 2010
K081778instrumentation industriesNS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORSSeptember 12, 2008
K050309viasys medsystemsPULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000March 25, 2005
K040991ambuAMBU DISPOSABLE PRESSURE MANOMETERJuly 22, 2004
K022402vital signsDISPOSABLE PRESSURE MANOMETERAugust 22, 2002
K003497engineered medical systemsDISPOSABLE PRESSURE MONITORNovember 30, 2000
K000959caradyneCRITERION 60 OR PM 60June 22, 2000
K992101caradyneCRITERION 40 OR PM 40January 6, 2000