K990512 is an FDA 510(k) clearance for the STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS. This device is classified as a Accessory Equipment, Cardiopulmonary Bypass (Class I - General Controls, product code KRI).
Submitted by Stoeckert Instrumente (North Attleboro, US). The FDA issued a Cleared decision on November 23, 1999, 278 days after receiving the submission on February 18, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4200.
| 510(k) Number | K990512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 1999 |
| Decision Date | November 23, 1999 |
| Days to Decision | 278 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRI — Accessory Equipment, Cardiopulmonary Bypass |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4200 |