510(k) K162582 ยท HIF Insufflator, Laparoscopic
HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
| Applicant | Fisher & Paykel Healthcare, Auckland, NZ |
| Decision | Substantially Equivalent, Jun 23, 2017 |
| Received | Sep 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162582
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.