510(k) K231407 ยท HIF Insufflator, Laparoscopic
StarFin
| Applicant | Premium Medical Technology, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Aug 29, 2023 |
| Received | May 15, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231407
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.