K173770 is an FDA 510(k) clearance for the OJR215 Pressure Relief Manifold. This device is classified as a Valve, Non-rebreathing (Class II - Special Controls, product code CBP).
Submitted by Fisher & Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on April 5, 2019, 480 days after receiving the submission on December 11, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5870.
| 510(k) Number | K173770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2017 |
| Decision Date | April 05, 2019 |
| Days to Decision | 480 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 |