The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bipap Vision Ventilatory Support.
| Device ID | K982454 |
| 510k Number | K982454 |
| Device Name: | BIPAP VISION VENTILATORY SUPPORT |
| Classification | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Applicant | RESPIRONICS, INC. 1501 ARDMORE BLVD. Pittsburgh, PA 15221 -4401 |
| Contact | Doug Mechlenburg |
| Correspondent | Doug Mechlenburg RESPIRONICS, INC. 1501 ARDMORE BLVD. Pittsburgh, PA 15221 -4401 |
| Product Code | MNT |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-15 |
| Decision Date | 1998-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30606959008855 | K982454 | 000 |
| 00606959002616 | K982454 | 000 |
| 00606959054158 | K982454 | 000 |
| 30606959026347 | K982454 | 000 |
| 30606959042316 | K982454 | 000 |
| 30606959042323 | K982454 | 000 |
| 30606959042330 | K982454 | 000 |
| 30606959042347 | K982454 | 000 |
| 30606959042354 | K982454 | 000 |
| 00606959042360 | K982454 | 000 |
| 00606959042377 | K982454 | 000 |
| 30606959049803 | K982454 | 000 |
| 00606959054165 | K982454 | 000 |