The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Remstar Pro M-series Cpap & Heated Humidifier System.
| Device ID | K072996 |
| 510k Number | K072996 |
| Device Name: | REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER 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 | 2007-10-24 |
| Decision Date | 2007-12-27 |
| Summary: | summary |