510(k) K260801 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Sensinel Cardiopulmonary Management (CPM) System
| Applicant | Analog Devices, Wilmington MA, US |
| Decision | Substantially Equivalent, Oct 16, 2026 |
| Received | Mar 11, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260801
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.