The following data is part of a premarket notification filed by Fisher & Paykel Healthcare Limited with the FDA for Ojr215 Pressure Relief Manifold.
| Device ID | K173770 |
| 510k Number | K173770 |
| Device Name: | OJR215 Pressure Relief Manifold |
| Classification | Valve, Non-rebreathing |
| Applicant | Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
| Contact | Adele Bindon |
| Correspondent | Adele Bindon Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki Auckland, NZ 2013 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-11 |
| Decision Date | 2019-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09420012448927 | K173770 | 000 |
| 09420012448903 | K173770 | 000 |
| 09420012448880 | K173770 | 000 |
| 09420012448866 | K173770 | 000 |
| 09420012448842 | K173770 | 000 |
| 09420012445278 | K173770 | 000 |