FDA 510(k) Applications for Medical Device Product Code "CAP"
(Monitor, Airway Pressure (Includes Gauge And/Or Alarm))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K102377 | A PLUS MEDICAL | VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 | 11/18/2010 |
| K040991 | AMBU, INC. | AMBU DISPOSABLE PRESSURE MANOMETER | 07/22/2004 |
| K140370 | BESMED HEALTH BUSINESS CORP. | DISPOSABLE PRESSURE MANOMETER | 06/19/2014 |
| K992101 | CARADYNE, LTD. | CRITERION 40 OR PM 40 | 01/06/2000 |
| K000959 | CARADYNE, LTD. | CRITERION 60 OR PM 60 | 06/22/2000 |
| K172284 | DRW Medical, LLC | NAPA LP-15 Airway Pressure Monitor | 02/09/2018 |
| K003497 | ENGINEERED MEDICAL SYSTEMS | DISPOSABLE PRESSURE MONITOR | 11/30/2000 |
| K201666 | Flexicare Medical Limited | SINGLE USE MANOMETER | 11/13/2020 |
| K122627 | GALEMED CORP. | GIO DIGITAL PRESSURE GUAGES | 08/22/2013 |
| K180510 | Instrumentation Industries, Inc. | NS 120P-TRS Airway Pressure Gauge | 05/01/2019 |
| K081778 | INSTRUMENTATION INDUSTRIES, INC. | NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS | 09/12/2008 |
| K122077 | INTERSURGICAL, INC. | MANOMETER | 01/10/2013 |
| K961318 | INTERTECH RESOURCES, INC. | 1ST RESPONSE DISPOSABLE MANOMETER | 12/17/1996 |
| K954486 | MERCURY MEDICAL | MERCURY AIRWAY PRESSURE MANOMETER | 04/25/1996 |
| K110119 | NEOFORCE GROUP INC | PRESSURE MANOMETER | 06/10/2011 |
| K973347 | SPIRACLE TECHNOLOGY | TSX PRM PULMONARY RESUSCITATION MONITOR | 07/23/1998 |
| K120118 | VENTLAB CORP. | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER | 05/24/2012 |
| K050309 | VIASYS MEDSYSTEMS | PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 | 03/25/2005 |
| K022402 | VITAL SIGNS, INC. | DISPOSABLE PRESSURE MANOMETER | 08/22/2002 |
| K103639 | VORTRAN MEDICAL TECHNOLOGY 1, INC. | VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC | 09/15/2011 |
| K182292 | VORTRAN Medical Technology 1, Inc. | VORTRAN APM-Plus | 09/18/2019 |
| K153733 | VORTRAN MEDICAL TECHNOLOGY 1, INC. | VORTRAN Manometer | 09/16/2016 |
| K143148 | Westmed, Inc. | Disposable Pressure Manometer (DPM) | 08/11/2015 |
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