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
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cadwell Industries, Inc. | Kennewick, WA, United States | Manufacturer, Specification developer | 3 | November 10, 1994 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer | 3 | September 17, 1996 | 0 | 1 | 0 | api.fda.gov |
| Dymedix Diagnostics Inc | Shoreview, MN, United States | Specification developer | 2 | April 26, 2004 | 0 | 0 | 0 | api.fda.gov |
| Hill-Rom, Inc. | Batesville, IN, United States | Complaint file establishment, Manufacturer | 2 | November 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 1 | August 16, 1991 | 0 | 0 | 0 | api.fda.gov |
| Circadia Health, Inc. | El Segundo, CA, United States | Specification developer | 1 | June 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | August 16, 1991 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 1 | March 15, 2012 | 0 | 0 | 0 | api.fda.gov |
| Gereonics, Inc. | Irvine, CA, United States | Manufacturer | 1 | February 8, 1999 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | November 4, 1982 | 0 | 0 | 0 | api.fda.gov |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | September 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Specification developer | 1 | November 24, 2009 | 0 | 0 | 0 | api.fda.gov |
| Aidar Health, Inc | Columbia, MD, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Analog Devices | Wilmington, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ActiGraph L.L.C. | Pensacola, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Foam Corporation dba MT. OLIVE MFG | Mooresville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Ppe Inc | Sealy, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Information Technologies | El Paso, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Happy Health | Austin, TX, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huxley Medical | Atlanta, GA, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infinium Medical, Inc. | Largo, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurovirtual Usa, Inc. | Fort Lauderdale, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nortech Systems, Inc. | Milaca, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices, LLC | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pepin MFG., Inc. | Lake City, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Murrysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Export, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sibel Health Inc. | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wesper Inc. Lic | Long Island City, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.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.