510(k) K191780 ยท HIF Insufflator, Laparoscopic
AP50/30 Insufflator with Insuflow Port
| Applicant | Lexion Medical, LLC, St. Paul MN, US |
| Decision | Substantially Equivalent, Aug 28, 2019 |
| Received | Jul 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191780
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.