The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Dreamstation 2 System, Dreamstation 2 Advanced System.
| Device ID | K200480 |
| 510k Number | K200480 |
| Device Name: | DreamStation 2 System, DreamStation 2 Advanced System |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 |
| Contact | Andy Zaltwanger |
| Correspondent | Andy Zaltwanger Respironics, Inc. 1740 Golden Mile Highway Monroeville, PA 15146 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-27 |
| Decision Date | 2020-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959062757 | K200480 | 000 |
| 00606959062849 | K200480 | 000 |
| 00606959062832 | K200480 | 000 |
| 00606959062825 | K200480 | 000 |
| 00606959062818 | K200480 | 000 |