Data / Medical devices / United States / CMI Health, Inc.
CMI Health, Inc.: FDA-registered device maker in Alpharetta, GA, United States, 1 510(k) clearance
CMI Health, Inc. is registered with the FDA (registration 3010427901) in Alpharetta, GA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 18, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010427901
- Address
- 5975 Shiloh Rd Ste 114, Alpharetta, GA, United States, 30005
- Owner or operator
- CMI Health, Inc. (10045508)
- Roles
- Specification developer
- First device listed
- April 22, 2024
- Registered through
- 2026
- Brand names listed
- Capno-H; Capnograph and Oximeter; PC-900B; VPOD CapOx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 18, 2018 | K170820 | Capnograph and Oximeter | CCK | Substantially Equivalent | Cmi Health, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 18, 2018. 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.