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 |