The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Zest Nasal Mask.
| Device ID | K083832 |
| 510k Number | K083832 |
| Device Name: | ZEST NASAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348 East Tamaki, NZ |
| Contact | Tina Mason |
| Correspondent | Tina Mason FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348 East Tamaki, NZ |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-23 |
| Decision Date | 2009-03-16 |
| Summary: | summary |