The following data is part of a premarket notification filed by Ergometrix, Inc. with the FDA for Cardio2 Cycle.
| Device ID | K926233 |
| 510k Number | K926233 |
| Device Name: | CARDIO2 CYCLE |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | ERGOMETRIX, INC. CONSTANCE G. BUNDY 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy ERGOMETRIX, INC. CONSTANCE G. BUNDY 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-11 |
| Decision Date | 1993-06-04 |