K893218 is an FDA 510(k) clearance for the AP900/PRP MODULE AND ACCESSORIES, MODIFICATION. 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 June 12, 1990, 411 days after receiving the submission on April 27, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K893218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1989 |
| Decision Date | June 12, 1990 |
| Days to Decision | 411 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 |