510(k) K260648 ยท GWL Amplifier, Physiological Signal
PolySense
| Applicant | Itamar Medical , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Oct 30, 2026 |
| Received | Feb 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260648
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.