510(k) K243966 ยท BZQ Monitor, Breathing Frequency
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
| Applicant | Faceheart Corp., Grand Cayman, KY |
| Decision | Substantially Equivalent, Apr 9, 2025 |
| Received | Dec 23, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243966
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.