The following data is part of a premarket notification filed by Cardiomedics, Inc. with the FDA for Cardiomedics Ecp System.
| Device ID | K010261 |
| 510k Number | K010261 |
| Device Name: | CARDIOMEDICS ECP SYSTEM |
| Classification | Device, Counter-pulsating, External |
| Applicant | CARDIOMEDICS, INC. 18872 BARDEEN AVE. Irvine, CA 92612 |
| Contact | John Hutchins |
| Correspondent | John Hutchins CARDIOMEDICS, INC. 18872 BARDEEN AVE. Irvine, CA 92612 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-29 |
| Decision Date | 2001-02-28 |