The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bipap Synchrony 2.
| Device ID | K092043 |
| 510k Number | K092043 |
| Device Name: | BIPAP SYNCHRONY 2 |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Zita Yurko |
| Correspondent | Zita Yurko RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-08-05 |
| Summary: | summary |