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Panels › Anesthesiology › Product code MNR · Class 2

Ventilatory Effort Recorder

Regulation 868.2375

6510(k)s in 12 months (165 all time)
1recalls in 12 months (8 all time)
8recalls that name a 510(k)
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Top companies in MNR

Company510(k)sRecalls
Itamar Medical150
Respironics, Inc.62
Advanced Brain Monitoring60
Snap Laboratories, LLC60
Compumedics Limited50
Embla Systems50
Resmed Germany, Inc.50
Huxley Medical40
Medcare Flaga40
Somnomedics GmbH40
Decided510(k)Device and applicantCode
Sep 24, 2026K260949Disposable Belts for Polysomnography (CNSAC)
CNSAC Medshop GmbH, DE
MNR
Jul 31, 2026K254042WatchPAT SW
Itamar Medical , Ltd., IL
MNR
Jul 15, 2026K260050WRAP System
Huneo, LLC
MNR
Jun 22, 2026K253148RX-1 Sleep
Vivaquant, Inc. Dba Rhythm Express
MNR
Apr 27, 2026K252628CASSIE
Wesper, Inc.
MNR
Dec 10, 2025K252497SANSA HSAT
Huxley Medical
MNR
Oct 29, 2025K250882SANSA HSAT
Huxley Medical
MNR
Sep 5, 2025K250460WatchPAT400 (WP400)
Itamar Medical , Ltd., IL
MNR
Aug 28, 2025K252383Somfit D
Compumedics Limited, AU
MNR
Jul 3, 2025K243220Onera STS 2 (ONERA STS 2)
Onera B.V., NL
MNR
Jun 18, 2025K242224Happy Health Home Sleep Test
Happy Health, Inc.
MNR
Mar 19, 2025K243092AcuPebble Ox (200)
Acurable Limited, GB
MNR
Feb 3, 2025K243268TipTraQ (TTQ001)
Pranaq Pte. , Ltd., SG
MNR
Jan 28, 2025K244027SANSA HSAT
Huxley Medical
MNR
Jan 8, 2025K242290DormoTech NLab
Dormotech Medical, Ltd., IL
MNR
Dec 18, 2024K242424Bluebird Single-Use Respiratory Effort Belt
Cadwell Industries, Inc.
MNR
Sep 6, 2024K231667Withings Sleep Rx
Withings, FR
MNR
Jul 26, 2024K233501“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)
Largan Medical Co., Ltd., TW
MNR
Jul 15, 2024K240285Huxley SANSA Home Sleep Apnea Test (1000-00)
Huxley Medical
MNR
Jun 4, 2024K240100SAM Model 9-10000
Snap Diagnostics, LLC
MNR
Feb 9, 2024K231355Aurora
Ensodata
MNR
Nov 30, 2023K231546Somfit
Compumedics Limited, AU
MNR
Aug 18, 2023K223573Onera Sleep Test System (Onera STS)
Onera B.V., NL
MNR
Mar 9, 2023K221816Wesper Lab
Wesper, Inc.
MNR
Feb 23, 2023K222579Belun Sleep System BLS-100
Belun Technology Company Limited, CN
MNR
Feb 3, 2023K222950AcuPebble OX100
Acurable Limited, GB
MNR
Jan 6, 2023K223675WatchPAT ONE (WP1)
Itamar Medical , Ltd., IL
MNR
Dec 21, 2022K220012BresoDX1
Bresotec, Inc., CA
MNR
Sep 14, 2022K222331WatchPAT300 (WP300)
Itamar Medical , Ltd., IL
MNR
Jul 11, 2022K220095ANNE Sleep
Sibel, Inc.
MNR
Jul 5, 2022K213360SleepCheckRx
Resapp Health, AU
MNR
Apr 6, 2022K210593Onera Sleep Test System (Onera STS)
Onera B.V., NL
MNR
Mar 21, 2022K203839WatchPAT200U (WP200U)
Itamar Medical , Ltd., IL
MNR
Feb 24, 2022K220028NightOwl
Ectosense NV, BE
MNR
Dec 21, 2021K203343Wesper Lab
Wesper, Inc.
MNR
Dec 16, 2021K213463NightOwl
Ectosense NV, BE
MNR
Jul 6, 2021K210480AcuPebble SA
Acurable Limited, GB
MNR
Dec 14, 2020K201495Maxxi Flow Sensor
Neurovirtual USA, Inc.
MNR
Aug 24, 2020K200695MATRx plus
Zephyr Sleep Technologies, CA
MNR
Jul 22, 2020K200654Rubicon SA System
Dymedix Diagnostics, Inc.
MNR
Mar 6, 2020K191031NightOwl
Ectosense NV, BE
MNR
Jan 16, 2020K191095Maxxi Snore Sensor
Neurovirtual USA, Inc.
MNR
Oct 29, 2019K191925MATRx Plus
Zephyr Sleep Technologies, CA
MNR
Oct 18, 2019K183625SomnaPatch
Respironics, Inc.
MNR
Sep 27, 2019K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable
Embla Systems, CA
MNR
Aug 14, 2019K182618SleepImage System
Mycardio, LLC Dba Sleepimage.
MNR
Jul 14, 2019K173974DROWZLE
Resonea, Inc.
MNR
Jun 24, 2019K171304Maxxi Rip Sensor
Neurovirtual USA, Inc.
MNR
Jun 5, 2019K183559WatchPAT ONE
Itamar Medical , Ltd., IL
MNR
Mar 1, 2019K173793XactTrace Single Use Respiratory Effort Belt System
Embla Systems, CA
MNR

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