The following data is part of a premarket notification filed by Fisher & Paykel Healthcare, Ltd. with the FDA for Pressure Manifold, Model Bc 110.
| Device ID | K040366 |
| 510k Number | K040366 |
| Device Name: | PRESSURE MANIFOLD, MODEL BC 110 |
| Classification | Valve, Non-rebreathing |
| Applicant | FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Contact | Robert Petry |
| Correspondent | Robert Petry FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE East Tamaki, NZ |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-13 |
| Decision Date | 2004-03-04 |
| Summary: | summary |