K040366 is an FDA 510(k) clearance for the PRESSURE MANIFOLD, MODEL BC 110. This device is classified as a Valve, Non-rebreathing (Class II - Special Controls, product code CBP).
Submitted by Fisher &Paykel Healthcare , Ltd. (East Tamaki, Auckland, NZ). The FDA issued a Cleared decision on March 4, 2004, 20 days after receiving the submission on February 13, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5870.
| 510(k) Number | K040366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2004 |
| Decision Date | March 04, 2004 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBP — Valve, Non-rebreathing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5870 |