K904164 is an FDA 510(k) clearance for the AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED. 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 September 6, 1991, 360 days after receiving the submission on September 11, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K904164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1990 |
| Decision Date | September 06, 1991 |
| Days to Decision | 360 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 |