510(k) K161554 ยท HIF Insufflator, Laparoscopic
ENDOFLATOR 40, ENDOFLATOR 50
| Applicant | KARL STORZ Endoscopy-America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Mar 2, 2017 |
| Received | Jun 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161554
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.