510(k) K252338 ยท BZD Ventilator, Non-Continuous (Respirator)
MySleepDash
| Applicant | Somnetics International, Inc. (Dba Transcend Inc), Fridley MN, US |
| Decision | Substantially Equivalent, Apr 17, 2026 |
| Received | Jul 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252338
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.