The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Opus Hc482 Direct Nasal Mask.
| Device ID | K063036 |
| 510k Number | K063036 |
| Device Name: | OPUS HC482 DIRECT NASAL MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, Auckland, NZ 2013 |
| Contact | Jayanti Karandikar |
| Correspondent | Jayanti Karandikar FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, Auckland, NZ 2013 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-03 |
| Decision Date | 2006-12-22 |
| Summary: | summary |