K913181 is an FDA 510(k) clearance for the AUTOLOGOUS BLOOD PROCESSING SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Lifestream Int'L, Inc. (The Woodlands, US). The FDA issued a Cleared decision on May 20, 1992, 307 days after receiving the submission on July 18, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K913181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1991 |
| Decision Date | May 20, 1992 |
| Days to Decision | 307 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |