Data / Medical devices / United States / Affirm Medical Technologies Ii, LLC
Affirm Medical Technologies Ii, LLC: FDA-registered device maker in Piedmont, CA, United States, 1 510(k) clearance
Affirm Medical Technologies Ii, LLC is registered with the FDA (registration 3047890096) in Piedmont, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 14, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3047890096
- Address
- 246 Sea View Ave, Piedmont, CA, United States, 94610
- Owner or operator
- Affirm Medical Technologies II, LLC (10096219)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 29, 2026
- Registered through
- 2026
- Brand names listed
- VisuBreath
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Complaint file establishment, 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 14, 2026 | K261633 | VisuBreath | CCK | Substantially Equivalent | Affirm Medical Technologies II, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 14, 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.