Data / Medical devices / Meter, Peak Flow, Spirometry / United States
FDA-registered makers of Meter, Peak Flow, Spirometry in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Meter, Peak Flow, Spirometry (product code BZH). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Meter, Peak Flow, Spirometry
- Product code
- BZH
- Country
- United States
Makers of Meter, Peak Flow, Spirometry in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Specification developer | 3 | October 25, 1996 | 0 | 0 | 0 | api.fda.gov |
| Monaghan Medical Corp. | Plattsburgh, NY, United States | Contract manufacturer, Manufacturer | 2 | April 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| BiometerPlus USA, Inc. | Fremont, CA, United States | Repackager or relabeler, Specification developer | 1 | May 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Fondcircle Inc. | Newport Beach, CA, United States | Specification developer | 1 | February 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Genia Medical, Inc. | Orlando, FL, United States | Specification developer | 1 | September 13, 2010 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Specification developer | 1 | March 29, 1996 | 0 | 0 | 0 | api.fda.gov |
| Aidar Health, Inc | Columbia, MD, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonic Manufacturing Technologies, Inc. | Fremont, CA, United States | Contract 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.