MNR · Class II · 21 CFR 868.2375

FDA Product Code MNR: Ventilatory Effort Recorder

Leading manufacturers include Itamar Medical , Ltd., Respironics, Inc. and Advanced Brain Monitoring, Inc..

164
Total
164
Cleared
200d
Avg days
1995
Since
164 devices
73–96 of 164
Cleared Aug 31, 2011
MORPHEUS OX
K111314
Widemed, Ltd.
Anesthesiology · 113d
Cleared Aug 31, 2011
MDRIVE
K111742
Embla Systems
Anesthesiology · 71d
Cleared Aug 12, 2011
ACCUSOM
K110486
Novasom, Inc.
Anesthesiology · 171d
Cleared Jul 07, 2011
APNEA RISK EVALUATION SYSTEM (ARES)
K111194
Advanced Brain Monitoring, Inc.
Anesthesiology · 70d
Cleared Apr 14, 2011
APNEA RISK EVALUATION SYSTEM (ARES)
K110705
Advanced Brain Monitoring, Inc.
Anesthesiology · 31d
Cleared Mar 18, 2011
SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
K110064
Snap Diagnostics, LLC
Anesthesiology · 67d
Cleared Jun 26, 2009
ALICE PDX
K090484
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 121d
Cleared Jan 26, 2009
GALAXY
K083874
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 28d
Cleared Jul 28, 2008
FLOCHANNEL
K081176
Chad Therapeutics, Inc.
Anesthesiology · 94d
Cleared Apr 14, 2008
COMPUMEDICS SOMTE PSG RECORDING SYSTEM
K072201
Compumedics Limited
Anesthesiology · 250d
Cleared Mar 20, 2008
SLEEP QUALITY
K070855
Dynadx Corporation
Anesthesiology · 358d
Cleared Nov 08, 2007
VITASCORE
K072014
Vitascore B.V.
Anesthesiology · 108d
Cleared Oct 03, 2007
APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600
K071230
Advanced Brain Monitoring, Inc.
Anesthesiology · 153d
Cleared Jul 18, 2007
SOMNOSCREEN EEG10-20
K071556
Somnomedics GmbH
Anesthesiology · 41d
Cleared Jun 15, 2007
APNEALINK
K070263
Resmed Germany, Inc.
Anesthesiology · 140d
Cleared May 05, 2007
NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
K070326
Widemed, Ltd.
Anesthesiology · 89d
Cleared Jan 24, 2007
SOMNOSCREEN
K060708
Somnomedics GmbH & Co. KG
Anesthesiology · 314d
Cleared Nov 21, 2006
CADWELL EASYNET NASAL PRESSURE MODULE
K061705
Cadwell Laboratories, Inc.
Anesthesiology · 158d
Cleared Oct 03, 2006
SANDMAN POCKET
K061996
Eb Neuro S.P.A.
Anesthesiology · 81d
Cleared Sep 06, 2006
MEDIBYTE, MODEL MP8
K061764
Braebon Medical Corp.
Anesthesiology · 76d
Cleared Jul 25, 2006
APNEALINK, MODEL 22302
K061405
Resmed Germany, Inc.
Anesthesiology · 67d
Cleared Dec 13, 2005
STARDUST II
K052573
Respironics, Inc.
Anesthesiology · 85d
Cleared Sep 15, 2005
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
K051313
Salter Labs
Anesthesiology · 119d
Cleared Jan 19, 2005
LIFESCREEN APNEA
K042745
Del Mar Reynolds Medical, Inc.
Anesthesiology · 107d