510(k) K261633 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
VisuBreath
| Applicant | Affirm Medical Technologies II, LLC, Piedmont CA, US |
| Decision | Substantially Equivalent, Jul 14, 2026 |
| Received | May 18, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261633
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.