The following data is part of a premarket notification filed by Vasomedical, Inc. with the FDA for Eecp Therapy System, Model Ts3.
| Device ID | K003469 |
| 510k Number | K003469 |
| Device Name: | EECP THERAPY SYSTEM, MODEL TS3 |
| Classification | Device, Counter-pulsating, External |
| Applicant | VASOMEDICAL, INC. 180 LINDEN AVE. Westbury, NY 11590 |
| Contact | Thomas R Varricchione |
| Correspondent | Thomas R Varricchione VASOMEDICAL, INC. 180 LINDEN AVE. Westbury, NY 11590 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-08 |
| Decision Date | 2000-12-06 |