K982454 is an FDA 510(k) clearance for the BIPAP VISION VENTILATORY SUPPORT. This device is classified as a Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (Class II - Special Controls, product code MNT).
Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on November 3, 1998, 111 days after receiving the submission on July 15, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K982454 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | July 15, 1998 |
| Decision Date | November 03, 1998 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | MNT — Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |