The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Sleepeasy Cpap System.
| Device ID | K091112 |
| 510k Number | K091112 |
| Device Name: | RESPIRONICS SLEEPEASY CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| 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 | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-17 |
| Decision Date | 2009-05-15 |
| Summary: | summary |