K881631 is an FDA 510(k) clearance for the BIODYNAMICS AUTOTRANSFUSION RESERVOIR. This device is classified as a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC).
Submitted by Biodynamics Corp. (Houston, US). The FDA issued a Cleared decision on September 9, 1988, 148 days after receiving the submission on April 14, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K881631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1988 |
| Decision Date | September 09, 1988 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5830 |