The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Remstar Plus Cpap System.
| Device ID | K010263 |
| 510k Number | K010263 |
| Device Name: | REMSTAR PLUS CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | David J Vanella |
| Correspondent | David J Vanella RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-29 |
| Decision Date | 2001-03-29 |