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
121–144 of 165
Cleared Sep 07, 2004
COMPASS F10 SYSTEM
K041904
Medcare Flaga
Anesthesiology · 54d
Cleared Jul 01, 2004
MICROMESAM BASIC-SET
K040576
Map Medizintechnik Fur Arzt Und Patient GmbH
Anesthesiology · 119d
Cleared Jun 30, 2004
PORTABLE SLEEP DATA RECORDER (PSDR)
K033402
Pro-Tech Services, Inc.
Anesthesiology · 250d
Cleared May 20, 2004
STARDUST II, MODEL 1011176
K021845
Respironics, Inc.
Anesthesiology · 715d
Cleared May 05, 2004
DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
K040069
Dymedix, Inc.
Anesthesiology · 112d
Cleared Apr 23, 2004
COMPUMEDICS SUMMIT IP
K040194
Compumedics USA, Ltd.
Anesthesiology · 86d
Cleared Oct 27, 2003
EMBLA N7000
K024322
Medcare Flaga
Anesthesiology · 305d
Cleared Aug 29, 2003
APLAB, MODEL 801D0030
K030379
Sector Medical Corp.
Anesthesiology · 205d
Cleared May 15, 2003
MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
K022506
Widemed, Ltd.
Anesthesiology · 289d
Cleared Apr 25, 2003
APNEACHECK
K022294
Im Systems
Anesthesiology · 283d
Cleared Mar 24, 2003
MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
K030611
Nellcor Puritan Bennett (Melville) , Ltd.
Anesthesiology · 26d
Cleared Feb 12, 2003
SLEEPSCREEN/APNOESCREEN CARDIO
K021138
Erich Jaeger GmbH
Anesthesiology · 309d
Cleared Jan 21, 2003
COMPUMEDICS SOMTE SYSTEM
K021176
Compumedics Limited
Anesthesiology · 284d
Cleared Aug 30, 2002
SLEEPFLO, MODEL 101501
K020607
Biomec, Inc.
Anesthesiology · 186d
Cleared Aug 07, 2002
ULTIMA SNORING MIKE, MODEL 0540
K020312
Braebon Medical Corp.
Anesthesiology · 189d
Cleared Jul 16, 2002
DEVILBISS SLEEP RECORDER MODEL # RM60
K012437
Sunrise Medical Hhg, Inc.
Anesthesiology · 350d
Cleared Jun 28, 2002
SNORE SAT RECORDER, MODEL SS41
K002159
Sagatech Electronics, Inc.
Anesthesiology · 711d
Cleared Jun 19, 2002
SLEEP PAT 200 DEVICE
K010156
Itamar Medical (C.M.) 1997 , Ltd.
Anesthesiology · 519d
Cleared Apr 22, 2002
MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
K013905
Pro-Tech Services, Inc.
Anesthesiology · 147d
Cleared Nov 06, 2001
WATCH-PAT 100
K010739
Itamar Medical (C.M.) 1997 , Ltd.
Anesthesiology · 239d
Cleared Mar 02, 2001
SNAP MODEL 6
K002095
Snap Laboratories, LLC
Anesthesiology · 234d
Cleared Dec 27, 2000
APNOESCREEN PRO, ALPHA SCREEN PRO
K000396
Erich Jaeger, Inc.
Anesthesiology · 324d
Cleared Dec 06, 2000
SLEEPSTRIP DISPOSABLE APNEA SCREENER
K002135
Influent , Ltd.
Anesthesiology · 145d
Cleared Nov 16, 2000
SILENT NIGHT V
K000253
Sleep Solutions, Inc.
Anesthesiology · 294d