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
73–96 of 165
Cleared Dec 20, 2011
MICHELE SLEEP SCORING SYSTEMS
K112102
Younes Sleep Technologies
Anesthesiology · 151d
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 Jun 02, 2011
WATCH-PAT 200S-3 (WP200S-3)
K102567
Itamar Medical , Ltd.
Anesthesiology · 268d
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 Sep 30, 2009
CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
K092003
MyCardio, LLC
Anesthesiology · 90d
Cleared Jun 26, 2009
ALICE PDX
K090484
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 121d
Cleared Jun 18, 2009
INOMAX DS (DELIVERY SYSTEM)
K090958
Ino Therapeutics, LLC
Anesthesiology · 73d
Cleared Mar 23, 2009
CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR
K082853
Inspired Technologies, Inc.
Anesthesiology · 175d
Cleared Mar 19, 2009
APNEALINK PLUS, MODEL: 22328
K083575
Resmed Germany, Inc.
Anesthesiology · 106d
Cleared Mar 06, 2009
SOMNOLYZER 24X7
K083620
The Siesta Group North America
Anesthesiology · 88d
Cleared Jan 26, 2009
GALAXY
K083874
Respironics Inc., Sleep & Home Respiratory Group
Anesthesiology · 28d
Cleared Jan 02, 2009
APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
K082968
Apneicare, LLC
Anesthesiology · 88d
Cleared Dec 04, 2008
HOLTER LX ANALYSIS
K081861
North East Monitoring, Inc.
Anesthesiology · 156d
Cleared Nov 07, 2008
NOX T3, NOXTURNAL (PC APPLICATION)
K082113
Nox Medical
Anesthesiology · 102d
Cleared Sep 18, 2008
SOMNOWATCH
K081485
Somnomedics GmbH
Anesthesiology · 113d
Cleared Sep 02, 2008
RMX PHYSIOLOGICAL DATA RECORDER
K080375
S.L.P. , Ltd.
Anesthesiology · 203d
Cleared Aug 14, 2008
WATCH-PAT 200S-2 (WP200S-2)
K081982
Itamar Medical
Anesthesiology · 34d
Cleared Aug 08, 2008
EMBLETTA GOLD
K073682
Embla Systems, Inc.
Anesthesiology · 224d
Cleared Aug 07, 2008
PROVENT NASAL CANNULA
K080983
Ventus Medical, Inc.
Anesthesiology · 122d
Cleared Jul 28, 2008
FLOCHANNEL
K081176
Chad Therapeutics, Inc.
Anesthesiology · 94d