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Data / Medical devices / Ventilatory Effort Recorder

Ventilatory Effort Recorder (MNR): 73 FDA-registered makers in 18 countries

73 establishments in 18 countries are registered with the FDA to make Ventilatory Effort Recorder (product code MNR, Class 2, 21 CFR 868.2375). 41 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 165 510(k) clearances under this code, the latest on September 24, 2026, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
MNR
Device class
2
Regulation
868.2375
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States35
Israel7
United Kingdom5
Singapore4
Germany3
China3
Australia2
Canada2
Mexico2
India2
Netherlands1
Iceland1
Hong Kong1
France1
Italy1
Taiwan1
Estonia1
Malaysia1

Makers of Ventilatory Effort Recorder

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Itamar MedicalCAESAREA Haifa, IsraelManufacturer9September 5, 2025000api.fda.gov
Itamar Medical Ltd. (Alon)Caesarea Haifa, IsraelManufacturer9September 5, 2025000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer8June 26, 2009010api.fda.gov
Compumedics LimitedMelbourne Victoria, AustraliaComplaint file establishment, Manufacturer4August 28, 2025000api.fda.gov
Huxley MedicalAtlanta, GA, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer4December 10, 2025000api.fda.gov
Natus Medical Incorporated Dba Excel-Tech Ltd. (xltek)OAKVILLE Ontario, CanadaComplaint file establishment, Manufacturer, Specification developer4September 27, 2019010api.fda.gov
Respironics, Inc.Mount Pleasant, PA, United StatesManufacturer4June 26, 2009000api.fda.gov
Somnomedics AGRANDERSACKER Bavaria, GermanyManufacturer4January 30, 2015000api.fda.gov
WATERMARK MEDICAL IncAtlanta, GA, United StatesSpecification developer4April 24, 2017000api.fda.gov
Neurovirtual Usa, Inc.Fort Lauderdale, FL, United StatesManufacturer3December 14, 2020000api.fda.gov
Onera B.V.Eindhoven Noord-Brabant, NetherlandsManufacturer3July 3, 2025000api.fda.gov
Snap Diagnostics, L.L.C.Vernon Hills, IL, United StatesManufacturer3June 4, 2024000api.fda.gov
Acurable LimitedLondon, United KingdomExporter to the US, Specification developer2February 3, 2023000api.fda.gov
Braebon Medical Corp.KANATA Ontario, CanadaManufacturer2September 6, 2006000api.fda.gov
Cadwell Industries, Inc.Kennewick, WA, United StatesManufacturer2December 18, 2024000api.fda.gov
Dymedix Diagnostics IncShoreview, MN, United StatesSpecification developer2May 5, 2004000api.fda.gov
Ensodata, Inc.Madison, WI, United StatesManufacturer2February 9, 2024000api.fda.gov
Jaeger Medical GmbHHOECHBERG Bavaria, GermanyComplaint file establishment, Manufacturer2February 12, 2003000api.fda.gov
Nox MedicalReykjavik, IcelandManufacturer, Specification developer2November 6, 2015010api.fda.gov
Resmed CorpSan Diego, CA, United StatesComplaint file establishment, Manufacturer2February 24, 2022000api.fda.gov
Resmed Pty Ltd.BELLA VISTA New South Wales, AustraliaManufacturer2April 30, 2015000api.fda.gov
Salter Labs de Mexico de S.A. de C.V.Chihuahua Mexico, MexicoContract manufacturer, Manufacturer2April 15, 2016000api.fda.gov
Wesper Inc. LicLong Island City, NY, United StatesManufacturer2March 9, 2023000api.fda.gov
Advanced Brain Monitoring, Inc.Carlsbad, CA, United StatesManufacturer1March 9, 2018000api.fda.gov
Apneicare, LLCColumbus, OH, United StatesManufacturer, Specification developer1January 2, 2009000api.fda.gov
Belun Technology Company LimitedNew Territories, Hong KongManufacturer1February 23, 2023000api.fda.gov
Cnsac Medshop GMBHTheilheim Bavaria, GermanySpecification developer1September 24, 2026000api.fda.gov
Dormotech Medical Ltd.Afula Northern, IsraelSpecification developer1January 8, 2025000api.fda.gov
Happy HealthAustin, TX, United StatesComplaint file establishment, Manufacturer1June 18, 2025000api.fda.gov
Huneo, LLCWilloughby Hills, OH, United StatesManufacturer, Specification developer1July 15, 2026000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1December 6, 2000000api.fda.gov
MycardioDenver, CO, United StatesManufacturer1August 14, 2019000api.fda.gov
Mallinckrodt Manufacturing LLCMadison, WI, United StatesManufacturer, Remanufacturer1June 18, 2009000api.fda.gov
Pranaq Pte. Ltd.Singapore Central Singapore, SingaporeManufacturer, Specification developer1February 3, 2025000api.fda.gov
ResMed Asia Pte. Ltd.Singapore South West, SingaporeContract manufacturer, Manufacturer1February 24, 2022000api.fda.gov
S.L.P. Ltd.Tel-Aviv Tel Aviv, IsraelManufacturer1October 6, 2004000api.fda.gov
Sibel Health Inc.Chicago, IL, United StatesManufacturer1July 11, 2022000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer1April 15, 2016000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer1April 15, 2016000api.fda.gov
VivaQuant, IncArden Hills, MN, United StatesManufacturer1June 22, 2026000api.fda.gov
WithingsIssy-les-Moulineaux Ile-de-France, FranceComplaint file establishment, Specification developer1September 6, 2024000api.fda.gov
B.Y. Medimor LtdTiberias Northern, IsraelContract manufacturer0000api.fda.gov
Brainmatterz, IncMcKinney, TX, United StatesManufacturer0000api.fda.gov
Cogent Technology LimitedFelixstowe Suffolk, United KingdomContract manufacturer0000api.fda.gov
Consolidated Research, Inc.Euclid, OH, United StatesManufacturer0000api.fda.gov
Convergent DentalWaltham, MA, United StatesManufacturer0000api.fda.gov
Ducommun LaBarge TechnologiesAppleton, WI, United StatesContract manufacturer0000api.fda.gov
Eb Neuro, S.P.A.FLORENCE Tuscany, ItalyContract manufacturer0000api.fda.gov
East West WisconsinWhitewater, WI, United StatesContract manufacturer0000api.fda.gov
GVS Filter Technology UK LtdLancaster Lancashire, United KingdomContract manufacturer0000api.fda.gov
Ixensor Co LtdTaipei, TaiwanContract manufacturer0000api.fda.gov
Innokas Medical Estonia OuTallinn Harjumaa, EstoniaContract manufacturer0000api.fda.gov
Jiangyin Sinbon Electronics Co LtdJiangyin Jiangsu, ChinaContract manufacturer0000api.fda.gov
Kimball Solutions Jasper, Inc.Jasper, IN, United StatesContract manufacturer0000api.fda.gov
Mehow Innovative (huizhou) Ltd.Huizhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Meiban Micro Pte LtdSingapore Central Singapore, SingaporeContract manufacturer0000api.fda.gov
Mirac, LLCLynchburg, OH, United StatesContract manufacturer0000api.fda.gov
Neurotronics, LLCAlachua, FL, United StatesManufacturer0000api.fda.gov
Oridion Medical 1987 Ltd.Jerusalem, IsraelSpecification developer0000api.fda.gov
P1 Technologies, Inc.Cave Spring, VA, United StatesContract manufacturer0000api.fda.gov
Pepin MFG., Inc.Lake City, MN, United StatesContract manufacturer0000api.fda.gov
Philips India Limited - Sleep & Respiratory Care Business UnitBengaluru Karnataka, IndiaContract manufacturer0000api.fda.gov
Remote Diagnostic Technologies Ltd.FARNBOROUGH Hampshire, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
REMwareTampa, FL, United StatesManufacturer0000api.fda.gov
ResMed CorpLithia Spgs, GA, United StatesContract manufacturer0000api.fda.gov
ResMed Malaysia Operations Sdn BhdSenai Johor, MalaysiaContract manufacturer0000api.fda.gov
Sanmina- Sci Israel Medical Systems Ltd.Maalot-Tarshiha Northern, IsraelContract manufacturer0000api.fda.gov
Skanray Technologies LimitedMysore Karnataka, IndiaComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Spacelabs Healthcare Ltd.HERTFORD Hertfordshire, United KingdomSpecification developer0010api.fda.gov
Sanbor Medical Xiamen, Inc.Xiamen Fujian, ChinaContract manufacturer0000api.fda.gov
Sanmina-SCI Systems Singapore Pte. Ltd.SINGAPORE North East, SingaporeContract manufacturer0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesContract manufacturer0000api.fda.gov
Westmed de Mexico, S.A de C.VNOGALES Sonora, MexicoContract manufacturer0000api.fda.gov

Updated September 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.