510(k) K233953 · BZQ Monitor, Breathing Frequency
Makani Science Respiration Monitoring System
| Applicant | Makani Science, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 28, 2025 |
| Received | Dec 15, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233953
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.