510(k) K221653 ยท IMD Pack, Hot Or Cold, Disposable
InfaTherm Disposable Infant Warming Mattress
| Applicant | International Biomedical, Austin TX, US |
| Decision | Substantially Equivalent, Oct 6, 2022 |
| Received | Jun 7, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221653
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.