510(k) K251480 ยท SFK Respiratory Effort Belt For Polysomnography
PV01 PVDF Effort Sensor
| Applicant | Neurotronics, LLC, Alachua FL, US |
| Decision | Substantially Equivalent, Aug 29, 2025 |
| Received | May 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251480
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.