K874925 is an FDA 510(k) clearance for the CPE 2000 CARDIO PULMONARY ERGOMETER. This device is classified as a Accessory Equipment, Cardiopulmonary Bypass (Class I - General Controls, product code KRI).
Submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on January 19, 1988, 48 days after receiving the submission on December 2, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4200.
| 510(k) Number | K874925 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1987 |
| Decision Date | January 19, 1988 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KRI — Accessory Equipment, Cardiopulmonary Bypass |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4200 |