K964363 is an FDA 510(k) clearance for the BIPAP DUET SYSTEM. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on January 30, 1997, 90 days after receiving the submission on November 1, 1996.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K964363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1996 |
| Decision Date | January 30, 1997 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |