The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Remstar Se.
| Device ID | K122769 |
| 510k Number | K122769 |
| Device Name: | REMSTAR SE |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Frank Kadi |
| Correspondent | Frank Kadi 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 | 2012-09-10 |
| Decision Date | 2012-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959049260 | K122769 | 000 |
| 00606959049253 | K122769 | 000 |