The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bipap Harmony Ventilatory Support System.
| Device ID | K031656 |
| 510k Number | K031656 |
| Device Name: | BIPAP HARMONY VENTILATORY SUPPORT SYSTEM |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-28 |
| Decision Date | 2003-07-30 |
| Summary: | summary |