Ventilatory Effort Recorder

FDA product code MNR · 159 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.2375
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1995-01-11 – 2026-09-24

MNR 2007-05-05

NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM

Applicant Widemed, Ltd.

K number K070326

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MNR 2007-01-24

SOMNOSCREEN

Applicant Somnomedics GmbH & Co. KG

K number K060708

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MNR 2006-11-21

CADWELL EASYNET NASAL PRESSURE MODULE

Applicant Cadwell Laboratories, Inc.

K number K061705

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MNR 2006-10-03

SANDMAN POCKET

Applicant Eb Neuro S.P.A.

K number K061996

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MNR 2006-09-06

MEDIBYTE, MODEL MP8

Applicant Braebon Medical Corp.

K number K061764

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MNR 2006-07-25

APNEALINK, MODEL 22302

Applicant Resmed Germany, Inc.

K number K061405

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MNR 2005-12-13

STARDUST II

Applicant Respironics, Inc.

K number K052573

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MNR 2005-09-15

BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER

Applicant Salter Labs

K number K051313

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MNR 2005-01-19

LIFESCREEN APNEA

Applicant Del Mar Reynolds Medical, Inc.

K number K042745

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MNR 2004-12-29

WATCH PAT 100S

Applicant Itamar Medical

K number K042916

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MNR 2004-12-21

UNIVERSAL XACTTRACE

Applicant Medcare Flaga

K number K043132

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MNR 2004-10-14

APNEA RISK EVALUATION SYSTEM (ARES)

Applicant Advanced Brain Monitoring, Inc.

K number K041662

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MNR 2004-10-06

SLEEPSENSE SLEEP SENSORS

Applicant S.L.P. , Ltd.

K number K042253

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MNR 2004-09-28

COMPASS M10 SYSTEM

Applicant Medcare Flaga

K number K041724

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MNR 2004-09-07

COMPASS F10 SYSTEM

Applicant Medcare Flaga

K number K041904

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MNR 2004-07-01

MICROMESAM BASIC-SET

Applicant Map Medizintechnik Fur Arzt Und Patient GmbH

K number K040576

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MNR 2004-06-30

PORTABLE SLEEP DATA RECORDER (PSDR)

Applicant Pro-Tech Services, Inc.

K number K033402

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MNR 2004-05-20

STARDUST II, MODEL 1011176

Applicant Respironics, Inc.

K number K021845

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MNR 2004-05-05

DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR

Applicant Dymedix, Inc.

K number K040069

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MNR 2004-04-23

COMPUMEDICS SUMMIT IP

Applicant Compumedics USA, Ltd.

K number K040194

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MNR 2003-10-27

EMBLA N7000

Applicant Medcare Flaga

K number K024322

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MNR 2003-08-29

APLAB, MODEL 801D0030

Applicant Sector Medical Corp.

K number K030379

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MNR 2003-05-15

MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM

Applicant Widemed, Ltd.

K number K022506

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MNR 2003-04-25

APNEACHECK

Applicant Im Systems

K number K022294

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MNR 2003-03-24

MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM

Applicant Nellcor Puritan Bennett (Melville) , Ltd.

K number K030611

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MNR 2003-02-12

SLEEPSCREEN/APNOESCREEN CARDIO

Applicant Erich Jaeger GmbH

K number K021138

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MNR 2003-01-21

COMPUMEDICS SOMTE SYSTEM

Applicant Compumedics Limited

K number K021176

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MNR 2002-08-30

SLEEPFLO, MODEL 101501

Applicant Biomec, Inc.

K number K020607

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MNR 2002-08-07

ULTIMA SNORING MIKE, MODEL 0540

Applicant Braebon Medical Corp.

K number K020312

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MNR 2002-07-16

DEVILBISS SLEEP RECORDER MODEL # RM60

Applicant Sunrise Medical Hhg, Inc.

K number K012437

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MNR 2002-06-28

SNORE SAT RECORDER, MODEL SS41

Applicant Sagatech Electronics, Inc.

K number K002159

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MNR 2002-06-19

SLEEP PAT 200 DEVICE

Applicant Itamar Medical (C.M.) 1997 , Ltd.

K number K010156

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MNR 2002-04-22

MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS

Applicant Pro-Tech Services, Inc.

K number K013905

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MNR 2001-11-06

WATCH-PAT 100

Applicant Itamar Medical (C.M.) 1997 , Ltd.

K number K010739

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MNR 2001-03-02

SNAP MODEL 6

Applicant Snap Laboratories, LLC

K number K002095

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MNR 2000-12-27

APNOESCREEN PRO, ALPHA SCREEN PRO

Applicant Erich Jaeger, Inc.

K number K000396

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MNR 2000-12-06

SLEEPSTRIP DISPOSABLE APNEA SCREENER

Applicant Influent , Ltd.

K number K002135

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MNR 2000-11-16

SILENT NIGHT V

Applicant Sleep Solutions, Inc.

K number K000253

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MNR 2000-02-02

SNAP MODEL 5

Applicant Snap Laboratories, LLC

K number K992322

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MNR 1999-08-18

SUZANNE

Applicant Nellcor Puritan Bennett, Inc.

K number K990565

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MNR 1999-06-01

ALPHAMED GEMINI SENSOR, SNORING SENSOR

Applicant Alphamed, Inc.

K number K990321

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MNR 1999-05-26

DIGI-SNAP

Applicant Snap Laboratories, LLC

K number K984169

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MNR 1999-04-19

SMARTRECORDER, MODEL 2500

Applicant Respironics, Inc.

K number K990199

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MNR 1999-03-19

SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500

Applicant Healthdyne Technologies, Inc.

K number K983572

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MNR 1998-10-30

SILENT NIGHT II

Applicant Sleep Solutions, Inc.

K number K981034

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MNR 1998-07-13

PRESSURE TRANSDUCER AIRFLOW SENSOR

Applicant Pro-Tech Services, Inc.

K number K982293

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MNR 1998-05-14

STARDUST

Applicant Respironics, Inc.

K number K973920

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MNR 1997-11-12

NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101

Applicant Neurotronics, Inc.

K number K971803

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MNR 1997-10-14

SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER

Applicant Bio-Logic Systems Corp.

K number K971501

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MNR 1997-10-01

OXI-SNAP

Applicant Snap Laboratories, LLC

K number K971184

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MNR 1997-03-11

SLEEP SYSTEM FOR CLINICS & RESEARCH

Applicant Compumedics Ptd , Ltd.

K number K955841

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MNR 1997-02-04

SLEEPWIZARD

Applicant Nellcor Puritan Bennett, Inc.

K number K964494

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MNR 1997-01-23

SILENT NIGHT I

Applicant Local Silence, Inc.

K number K963597

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MNR 1996-08-22

BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER

Applicant Bio-Logic Systems Corp.

K number K962103

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MNR 1995-10-26

SNAP TESTING DEVICE

Applicant Snap Laboratories, LLC

K number K944524

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MNR 1995-09-19

SLEEP TEST(TM)

Applicant Cns, Inc.

K number K950273

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MNR 1995-05-04

BODY POSITION INDICATOR, MODEL BPI1

Applicant Pro-Tech, Inc.

K number K940013

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MNR 1995-04-21

MODEL# 7500 SURVEYOR

Applicant Devilbiss Health Care, Inc.

K number K944611

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MNR 1995-01-11

SNORING MICROPHONE, SM1

Applicant Pro-Tech, Inc.

K number K940015

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