MNR · Class II · 21 CFR 868.2375

FDA Product Code MNR: Ventilatory Effort Recorder

Leading manufacturers include Itamar Medical , Ltd., Respironics, Inc. and Huxley Medical.

164
Total
164
Cleared
200d
Avg days
1995
Since
164 devices
49–72 of 164
Cleared Mar 09, 2018
Positional Sleep Assessment System (PoSAS) software
K172799
Advanced Brain Monitoring
Anesthesiology · 172d
Cleared Apr 15, 2016
BiNAPS Nasal Airflow and Snore Transducer
K151874
Salter Labs
Anesthesiology · 281d
Cleared Oct 17, 2013
SOMNOLYZER 24X7
K131994
Respironics, Inc.
Anesthesiology · 111d
Cleared Nov 21, 2006
CADWELL EASYNET NASAL PRESSURE MODULE
K061705
Cadwell Laboratories, Inc.
Anesthesiology · 158d
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 May 20, 2004
STARDUST II, MODEL 1011176
K021845
Respironics, Inc.
Anesthesiology · 715d
Cleared Aug 18, 1999
SUZANNE
K990565
Nellcor Puritan Bennett, Inc.
Anesthesiology · 177d
Cleared Apr 19, 1999
SMARTRECORDER, MODEL 2500
K990199
Respironics, Inc.
Anesthesiology · 88d
Cleared May 14, 1998
STARDUST
K973920
Respironics, Inc.
Anesthesiology · 211d
Cleared Oct 14, 1997
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
K971501
Bio-Logic Systems Corp.
Anesthesiology · 173d
Cleared Feb 04, 1997
SLEEPWIZARD
K964494
Nellcor Puritan Bennett, Inc.
Anesthesiology · 88d
Cleared Aug 22, 1996
BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER
K962103
Bio-Logic Systems Corp.
Anesthesiology · 84d