MNR · Class II · 21 CFR 868.2375

FDA Product Code MNR: Ventilatory Effort Recorder

Leading manufacturers include Itamar Medical , Ltd., Respironics, Inc. and Snap Laboratories, LLC.

165
Total
165
Cleared
200d
Avg days
1995
Since
165 devices
97–120 of 165
Cleared Jun 09, 2008
WATCH-PAT 200I (WP200I)
K081037
Itamar Medical
Anesthesiology · 59d
Cleared May 23, 2008
SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
K080321
Snap Laboratories, LLC
Anesthesiology · 107d
Cleared May 23, 2008
WATCH-PAT MODEL 100S-2
K080427
Itamar Medical
Anesthesiology · 98d
Cleared Apr 18, 2008
HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM
K073269
Hypnocore, Ltd.
Anesthesiology · 149d
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
Cleared Dec 29, 2004
WATCH PAT 100S
K042916
Itamar Medical
Anesthesiology · 69d
Cleared Dec 21, 2004
UNIVERSAL XACTTRACE
K043132
Medcare Flaga
Anesthesiology · 39d
Cleared Oct 14, 2004
APNEA RISK EVALUATION SYSTEM (ARES)
K041662
Advanced Brain Monitoring, Inc.
Anesthesiology · 118d
Cleared Oct 06, 2004
SLEEPSENSE SLEEP SENSORS
K042253
S.L.P. , Ltd.
Anesthesiology · 47d
Cleared Sep 28, 2004
COMPASS M10 SYSTEM
K041724
Medcare Flaga
Anesthesiology · 96d