The following data is part of a premarket notification filed by Cardiomedics, Inc. with the FDA for Cardiomedics External Counterpulsation System.
| Device ID | K872034 |
| 510k Number | K872034 |
| Device Name: | CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM |
| Classification | Device, Counter-pulsating, External |
| Applicant | CARDIOMEDICS, INC. 19401 S. VERMONT AVENUE (B- 100) Torrance, CA 90502 |
| Contact | Joseph J Schwoebel |
| Correspondent | Joseph J Schwoebel CARDIOMEDICS, INC. 19401 S. VERMONT AVENUE (B- 100) Torrance, CA 90502 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-27 |
| Decision Date | 1987-09-18 |