The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Single Use Oral Mask, Model Hc455a.
| Device ID | K023670 |
| 510k Number | K023670 |
| Device Name: | SINGLE USE ORAL MASK, MODEL HC455A |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, Auckland, NZ |
| Contact | Robert Petry |
| Correspondent | Robert Petry FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, Auckland, NZ |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-31 |
| Decision Date | 2003-06-12 |
| Summary: | summary |