K895849 is an FDA 510(k) clearance for the RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM. This device is classified as a Ventilator, External Body, Negative Pressure, Adult (cuirass) (Class II - Special Controls, product code BYT).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on December 22, 1989, 80 days after receiving the submission on October 3, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5935.
| 510(k) Number | K895849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1989 |
| Decision Date | December 22, 1989 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYT — Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5935 |