510(k) K240646 ยท GWL Amplifier, Physiological Signal
DreamClear
| Applicant | Somnomed Technologies Inc., Doing Business AS Remware, Tampa FL, US |
| Decision | Substantially Equivalent, Sep 4, 2024 |
| Received | Mar 7, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240646
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.