The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Acute Care Face Mask, Model Rt040.
| Device ID | K060044 |
| 510k Number | K060044 |
| Device Name: | ACUTE CARE FACE MASK, MODEL RT040 |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. P.O BOX 14-348 Panmure, Auckland, NZ 1701 |
| Contact | Brett Whiston |
| Correspondent | Brett Whiston FISHER & PAYKEL HEALTHCARE, LTD. P.O BOX 14-348 Panmure, Auckland, NZ 1701 |
| Product Code | MNT |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-06 |
| Decision Date | 2006-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012429902 | K060044 | 000 |
| 09420012429896 | K060044 | 000 |
| 09420012429889 | K060044 | 000 |