510(k) K242438 ยท NHJ Device, Positive Pressure Breathing, Intermittent
Clearo
| Applicant | Breas Medical AB, Molnlycke, SE |
| Decision | Substantially Equivalent, May 16, 2025 |
| Received | Aug 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242438
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.