K992635 is an FDA 510(k) clearance for the INTERFACE MODULE IDDD. 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 December 20, 1999, 136 days after receiving the submission on August 6, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4200.
| 510(k) Number | K992635 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1999 |
| Decision Date | December 20, 1999 |
| Days to Decision | 136 days |
| Submission Type | Special |
| 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 |