K862684 is an FDA 510(k) clearance for the AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on October 17, 1986, 94 days after receiving the submission on July 15, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K862684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1986 |
| Decision Date | October 17, 1986 |
| Days to Decision | 94 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 |