K860306 is an FDA 510(k) clearance for the BT-795/P AUTOMATED AUTOTRANS. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on March 6, 1986, 37 days after receiving the submission on January 28, 1986.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K860306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 1986 |
| Decision Date | March 06, 1986 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |