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Data / Medical devices / Monitor, Breathing Frequency / United States

FDA-registered makers of Monitor, Breathing Frequency in the United States: 39 establishments

39 establishments in the United States are registered with the FDA to make Monitor, Breathing Frequency (product code BZQ). 12 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Monitor, Breathing Frequency
Product code
BZQ
Country
United States

Makers of Monitor, Breathing Frequency in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Cadwell Industries, Inc.Kennewick, WA, United StatesManufacturer, Specification developer3November 10, 1994000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer3September 17, 1996010api.fda.gov
Dymedix Diagnostics IncShoreview, MN, United StatesSpecification developer2April 26, 2004000api.fda.gov
Hill-Rom, Inc.Batesville, IN, United StatesComplaint file establishment, Manufacturer2November 18, 2022000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer1August 16, 1991000api.fda.gov
Circadia Health, Inc.El Segundo, CA, United StatesSpecification developer1June 24, 2020000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer1August 16, 1991000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer1March 15, 2012000api.fda.gov
Gereonics, Inc.Irvine, CA, United StatesManufacturer1February 8, 1999000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer1November 4, 1982000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer1September 5, 2018000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer1November 24, 2009000api.fda.gov
Aidar Health, IncColumbia, MD, United StatesManufacturer, Specification developer0000api.fda.gov
Analog DevicesWilmington, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
ActiGraph L.L.C.Pensacola, FL, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
Creative Foam Corporation dba MT. OLIVE MFGMooresville, IN, United StatesContract manufacturer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Ever Ppe IncSealy, TX, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
Happy HealthAustin, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Huxley MedicalAtlanta, GA, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Infinium Medical, Inc.Largo, FL, United StatesManufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Neurovirtual Usa, Inc.Fort Lauderdale, FL, United StatesManufacturer0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices, LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
Pepin MFG., Inc.Lake City, MN, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Sibel Health Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer0010api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Wesper Inc. LicLong Island City, NY, United StatesManufacturer0000api.fda.gov

Updated November 2, 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.