The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Limited with the FDA for F&p Simplus Full Face Mask.
| Device ID | K130328 |
| 510k Number | K130328 |
| Device Name: | F&P SIMPLUS FULL FACE MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | FISHER & PAYKEL HEALTHCARE LIMITED 15 MAURICE PAYKEL PLACE EAST TAMAKI Auckland, NZ 2013 |
| Contact | Sue Cho |
| Correspondent | Sue Cho FISHER & PAYKEL HEALTHCARE LIMITED 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 | 2013-02-11 |
| Decision Date | 2013-06-05 |
| Summary: | summary |