The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Flexifit Hc432 Full Face Mask.
| Device ID | K061236 |
| 510k Number | K061236 |
| Device Name: | FLEXIFIT HC432 FULL FACE MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, Auckland, NZ 1701 |
| Contact | Reena Daken |
| Correspondent | Reena Daken FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, Auckland, NZ 1701 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-03 |
| Decision Date | 2006-08-29 |
| Summary: | summary |