The following data is part of a premarket notification filed by Fisher & Paykel Healthcare with the FDA for Humigard Surgical Humidification System, Humigard Humdified Insufflation Kit.
| Device ID | K162582 |
| 510k Number | K162582 |
| Device Name: | HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit |
| Classification | Insufflator, Laparoscopic |
| Applicant | FISHER & PAYKEL HEALTHCARE 15 MAURICE PAYKEL PLACE, EAST TAMAKI Auckland, NZ 2013 |
| Contact | Tina O'brien |
| Correspondent | Nicole Senasac FISHER & PAYKEL HEALTHCARE 15 MAURICE PAYKEL PLACE, EAST TAMAKI Auckland, NZ 2013 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-15 |
| Decision Date | 2017-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012433985 | K162582 | 000 |