The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bipap Avaps Ventilatory Support System.
| Device ID | K092818 |
| 510k Number | K092818 |
| Device Name: | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-14 |
| Decision Date | 2010-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959045590 | K092818 | 000 |
| 00606959040694 | K092818 | 000 |
| 00606959040700 | K092818 | 000 |
| 00606959040717 | K092818 | 000 |
| 00606959040724 | K092818 | 000 |
| 00606959040748 | K092818 | 000 |
| 00606959040847 | K092818 | 000 |
| 00606959040854 | K092818 | 000 |
| 00606959040885 | K092818 | 000 |
| 00606959043503 | K092818 | 000 |
| 00606959045545 | K092818 | 000 |
| 00606959040731 | K092818 | 000 |