Data / Medical devices / Spirometer, Monitoring (W/Wo Alarm) / United States
FDA-registered makers of Spirometer, Monitoring (W/Wo Alarm) in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Spirometer, Monitoring (W/Wo Alarm) (product code BZK). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Spirometer, Monitoring (W/Wo Alarm)
- Product code
- BZK
- Country
- United States
Makers of Spirometer, Monitoring (W/Wo Alarm) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Respironics Novametrix, LLC | Andover, MA, United States | Specification developer | 3 | June 2, 2011 | 0 | 1 | 0 | api.fda.gov |
| Ambulatory Monitoring, Inc. | Ardsley, NY, United States | Repackager or relabeler, Specification developer | 1 | January 26, 1978 | 0 | 0 | 0 | api.fda.gov |
| Anesthesia Associates, Inc. | San Marcos, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 1 | January 4, 1991 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 1 | October 25, 1993 | 0 | 0 | 0 | api.fda.gov |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cognita Labs LLC | Santa Ana, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | 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 | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.