K830735 is an FDA 510(k) clearance for the BT 795/A AUTOTRANS. This device is classified as a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC).
Submitted by Electromedics, Inc. (Walker, US). The FDA issued a Cleared decision on May 2, 1983, 55 days after receiving the submission on March 8, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K830735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1983 |
| Decision Date | May 02, 1983 |
| Days to Decision | 55 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 |