BZQ · Class II · 21 CFR 868.2375

FDA Product Code BZQ: Monitor, Breathing Frequency

Leading manufacturers include Aequitron Medical, Inc., Healthdyne, Inc. and Earlysense, Ltd..

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 Jun 23, 2010
KAI SPOT MODEL KMS 200
K100773
Kai Medical, Inc.
Anesthesiology · 97d
Cleared May 24, 2010
EVERON 1.0
K092062
Earlysense, Ltd.
Anesthesiology · 320d
Cleared Nov 24, 2009
PNEUMOTHERML, MODEL: 5800
K092685
Salter Labs
Anesthesiology · 83d
Cleared Jun 05, 2009
KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
K090273
Kai Sensors, Inc.
Anesthesiology · 121d
Cleared Mar 25, 2009
EVERON
K082465
Earlysense, Ltd.
Anesthesiology · 210d
Cleared Jul 25, 2008
SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
K080922
Salter Labs, Division of Regulatory Affairs
Anesthesiology · 115d
Cleared Nov 15, 2007
EARLYSENSE ES-16 SYSTEM
K070375
Earlysense, Ltd.
Anesthesiology · 280d
Cleared Jun 13, 2007
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
K062883
Gereonics, Inc.
Anesthesiology · 260d
Cleared Sep 30, 2005
ANDROFLOW - RESPIRATORY RATE MONITOR
K051779
Andromed, Inc.
Anesthesiology · 91d
Cleared Apr 26, 2004
DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
K040605
Dymedix, Inc.
Anesthesiology · 49d
Cleared Feb 05, 2001
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
K003704
Optovent AB
Anesthesiology · 66d
Cleared Aug 25, 2000
ULTIMA SMARTBELT, MODEL 0560
K001743
Braebon Medical Corp.
Anesthesiology · 78d
Cleared May 11, 2000
RESPIRATORY BELT SENSOR, MODEL 6000S
K001030
Dymedix, Inc.
Anesthesiology · 42d
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