The following data is part of a premarket notification filed by Vasomedical, Inc. with the FDA for Eecp Therapy System Model Ts3 With Pulse Oximetry And Enhanced External Counterpulsation Eecp Mc-2 External Counter.
| Device ID | K020857 |
| 510k Number | K020857 |
| Device Name: | EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERPULSATION EECP MC-2 EXTERNAL COUNTER |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-18 |
| Decision Date | 2002-06-14 |
| Summary: | summary |