The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bipap Pro 2 Bi-level System With Bi-flex.
| Device ID | K043607 |
| 510k Number | K043607 |
| Device Name: | BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX |
| Classification | Ventilator, Non-continuous (respirator) |
| 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 | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-30 |
| Decision Date | 2005-01-28 |
| Summary: | summary |