BZQ · Class II · 21 CFR 868.2375

FDA Product Code BZQ: Monitor, Breathing Frequency

Leading manufacturers include Aequitron Medical, Inc., Healthdyne, Inc. and Edentec Corp..

176
Total
176
Cleared
157d
Avg days
1976
Since
176 devices
25–48 of 176
Cleared Jun 13, 2014
CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM
K133661
Earlysense, Ltd.
Anesthesiology · 196d
Cleared Mar 26, 2014
INTELLIVUE CL RESPIRATION POD
K132320
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Anesthesiology · 244d
Cleared Dec 26, 2013
NEUROVISION MEDICAL MOTION SENSOR
K130570
Neurovision Medical Products, Inc.
Anesthesiology · 297d
Cleared Dec 18, 2013
EARLYSENSE
K131379
Earlysense, Ltd.
Anesthesiology · 218d
Cleared Apr 12, 2013
NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
K122223
Philips Medizin Systeme Boeblingen GmbH
Anesthesiology · 261d
Cleared Jun 08, 2012
EARLYSENSE (EVERON) SYSTEM
K120465
Earlysense, Ltd.
Anesthesiology · 114d
Cleared Mar 15, 2012
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
K111933
Covidien
Anesthesiology · 251d
Cleared Jul 21, 2011
SLEEPMINDER BREATHING FREQUENCY INDICATOR
K103631
Biancamed Limited
Anesthesiology · 220d
Cleared Nov 24, 2009
PNEUMOTHERML, MODEL: 5800
K092685
Salter Labs
Anesthesiology · 83d
Cleared Sep 30, 2005
ANDROFLOW - RESPIRATORY RATE MONITOR
K051779
Andromed, Inc.
Anesthesiology · 91d
Cleared Apr 28, 1999
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K991411
Gereonics, Inc.
Anesthesiology · 33d
Cleared Feb 08, 1999
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K983449
Gereonics, Inc.
Anesthesiology · 131d
Cleared Feb 02, 1999
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
K981725
Optovent, Inc.
Anesthesiology · 263d
Cleared Dec 30, 1998
ULTIMA AIRFLOW PRESSURE SENSOR
K984431
Braebon Medical Corp.
Anesthesiology · 19d
Cleared Oct 05, 1998
ULTIMA AIRFLOW SENSOR, 0510
K981445
Braebon Medical Corp.
Anesthesiology · 166d
Cleared Oct 05, 1998
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K982550
Respironics, Inc.
Anesthesiology · 75d
Cleared Sep 11, 1998
ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
K982216
Braebon Medical Corp.
Anesthesiology · 80d
Cleared Jun 26, 1998
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
K981728
Alexander Mfg. Co.
Anesthesiology · 42d
Cleared Apr 18, 1997
MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
K961972
Aequitron Medical, Inc.
Anesthesiology · 333d
Cleared Mar 06, 1997
COROMETRICS MODEL 510 AND 511 MONITOR
K962781
Ge Medical Systems Information Technologies
Anesthesiology · 232d
Cleared Sep 17, 1996
THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR
K960851
Pro-Tech Services, Inc.
Anesthesiology · 200d
Cleared Feb 06, 1996
OXIFLOW DIGITAL RECORDER
K953363
Edentec Corp.
Anesthesiology · 204d
Cleared Jul 25, 1995
MODEL 510 INFANT MONITOR
K943308
Ge Medical Systems Information Technologies
Anesthesiology · 382d
Cleared Jun 02, 1995
MODEL 511 INFANT MONITOR
K942170
Ge Medical Systems Information Technologies
Anesthesiology · 394d