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
49–72 of 164
Cleared Mar 01, 2019
XactTrace Single Use Respiratory Effort Belt System
K173793
Embla Systems
Anesthesiology · 442d
Cleared Nov 21, 2018
MATRx Plus
K181996
Zephyr Sleep Technologies
Anesthesiology · 118d
Cleared Aug 17, 2018
Watch-PAT300
K180775
Itamar Medical , Ltd.
Anesthesiology · 147d
Cleared Mar 09, 2018
Positional Sleep Assessment System (PoSAS) software
K172799
Advanced Brain Monitoring
Anesthesiology · 172d
Cleared Oct 13, 2017
SleepImage System
K163696
Mycardio, LLC Dba Sleepimage.
Anesthesiology · 288d
Cleared May 05, 2017
MATRx plus
K163665
Zephyr Sleep Technologies
Anesthesiology · 129d
Cleared Apr 24, 2017
Apnea Risk Evaluation System (ARES), Model 620
K160499
Watermark Medical
Anesthesiology · 426d
Cleared Feb 24, 2017
Watch-PAT200U
K161579
Itamar Medical , Ltd.
Anesthesiology · 262d
Cleared Jul 26, 2016
Watch-PAT200U
K153070
Itamar Medical , Ltd.
Anesthesiology · 278d
Cleared Apr 15, 2016
BiNAPS Nasal Airflow and Snore Transducer
K151874
Salter Labs
Anesthesiology · 281d
Cleared Mar 18, 2016
AUDICOR CA300/CC100 Analyzer with SDB
K151433
Inovise Medical, Inc.
Anesthesiology · 295d
Cleared Nov 06, 2015
Nox RIP Belts & Cables
K151361
Nox Medical Ehf
Anesthesiology · 169d
Cleared Nov 05, 2015
SnoreSounds
K150102
Appian Medical, Inc.
Anesthesiology · 289d
Cleared Apr 30, 2015
ApneaLink Air
K143272
Resmed Germany, Inc.
Anesthesiology · 167d
Cleared Jan 30, 2015
SOMNOTOUCH RESP
K140861
Somnomedics GmbH
Anesthesiology · 302d
Cleared May 30, 2014
WATCH-PAT200U (WP200U)
K133859
Itamar Medical , Ltd.
Anesthesiology · 162d
Cleared Apr 11, 2014
AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
K131883
Inovise Medical, Inc.
Anesthesiology · 290d
Cleared Nov 08, 2013
APNEALINK PRO
K131932
Resmed Germany, Inc.
Anesthesiology · 134d
Cleared Oct 17, 2013
SOMNOLYZER 24X7
K131994
Respironics, Inc.
Anesthesiology · 111d
Cleared Jul 10, 2013
QDC-PRO, AND NOX-RIP
K124062
Nox Medical
Anesthesiology · 191d
Cleared Feb 21, 2013
EMBLETTA MPR
K122516
Embla Systems
Anesthesiology · 188d
Cleared Jan 09, 2012
APNEA RISK EVALUATION SYSTEM (ARES)
K112514
Advanced Brain Monitoring, Inc.
Anesthesiology · 132d
Cleared Dec 27, 2011
SLEEPSTRIP II
K112822
S.L.P. , Ltd.
Anesthesiology · 90d
Cleared Dec 20, 2011
MICHELE SLEEP SCORING SYSTEMS
K112102
Younes Sleep Technologies
Anesthesiology · 151d