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
49–72 of 165
Cleared Jun 05, 2019
WatchPAT ONE
K183559
Itamar Medical , Ltd.
Anesthesiology · 167d
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