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
145–165 of 165
Cleared Feb 02, 2000
SNAP MODEL 5
K992322
Snap Laboratories, LLC
Anesthesiology · 205d
Cleared Aug 18, 1999
SUZANNE
K990565
Nellcor Puritan Bennett, Inc.
Anesthesiology · 177d
Cleared Jun 01, 1999
ALPHAMED GEMINI SENSOR, SNORING SENSOR
K990321
Alphamed, Inc.
Anesthesiology · 120d
Cleared May 26, 1999
DIGI-SNAP
K984169
Snap Laboratories, LLC
Anesthesiology · 187d
Cleared Apr 19, 1999
SMARTRECORDER, MODEL 2500
K990199
Respironics, Inc.
Anesthesiology · 88d
Cleared Mar 19, 1999
SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
K983572
Healthdyne Technologies, Inc.
Anesthesiology · 157d
Cleared Oct 30, 1998
SILENT NIGHT II
K981034
Sleep Solutions, Inc.
Anesthesiology · 225d
Cleared Jul 13, 1998
PRESSURE TRANSDUCER AIRFLOW SENSOR
K982293
Pro-Tech Services, Inc.
Anesthesiology · 12d
Cleared May 14, 1998
STARDUST
K973920
Respironics, Inc.
Anesthesiology · 211d
Cleared Nov 12, 1997
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101
K971803
Neurotronics, Inc.
Anesthesiology · 184d
Cleared Oct 14, 1997
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
K971501
Bio-Logic Systems Corp.
Anesthesiology · 173d
Cleared Oct 01, 1997
OXI-SNAP
K971184
Snap Laboratories, LLC
Anesthesiology · 183d
Cleared Mar 11, 1997
SLEEP SYSTEM FOR CLINICS & RESEARCH
K955841
Compumedics Ptd , Ltd.
Anesthesiology · 445d
Cleared Feb 04, 1997
SLEEPWIZARD
K964494
Nellcor Puritan Bennett, Inc.
Anesthesiology · 88d
Cleared Jan 23, 1997
SILENT NIGHT I
K963597
Local Silence, Inc.
Anesthesiology · 136d
Cleared Aug 22, 1996
BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER
K962103
Bio-Logic Systems Corp.
Anesthesiology · 84d
Cleared Oct 26, 1995
SNAP TESTING DEVICE
K944524
Snap Laboratories, LLC
Anesthesiology · 405d
Cleared Sep 19, 1995
SLEEP TEST(TM)
K950273
Cns, Inc.
Anesthesiology · 239d
Cleared May 04, 1995
BODY POSITION INDICATOR, MODEL BPI1
K940013
Pro-Tech, Inc.
Anesthesiology · 485d
Cleared Apr 21, 1995
MODEL# 7500 SURVEYOR
K944611
Devilbiss Health Care, Inc.
Anesthesiology · 214d
Cleared Jan 11, 1995
SNORING MICROPHONE, SM1
K940015
Pro-Tech, Inc.
Anesthesiology · 372d