The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Hospital Full Face Mask Non Vented, Model: Rt041.
| Device ID | K083122 |
| 510k Number | K083122 |
| Device Name: | HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348 East Tamaki, NZ |
| Contact | Stephanie Coste |
| Correspondent | Stephanie Coste FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE P.O. BOX 14348 East Tamaki, NZ |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-22 |
| Decision Date | 2009-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012429872 | K083122 | 000 |
| 09420012429865 | K083122 | 000 |
| 09420012429858 | K083122 | 000 |