K901138 is an FDA 510(k) clearance for the AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES. 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 June 18, 1990, 98 days after receiving the submission on March 12, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K901138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1990 |
| Decision Date | June 18, 1990 |
| Days to Decision | 98 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 |