The following data is part of a premarket notification filed by Vasogenics, Inc. with the FDA for Vasogenics Eecp-mc2.
| Device ID | K940264 |
| 510k Number | K940264 |
| Device Name: | VASOGENICS EECP-MC2 |
| Classification | Device, Counter-pulsating, External |
| Applicant | VASOGENICS, INC. 38 MARKET ST. Port Jefferson Station, NY 11776 |
| Contact | John C.k. Hui, Ph.d. |
| Correspondent | John C.k. Hui, Ph.d. VASOGENICS, INC. 38 MARKET ST. Port Jefferson Station, NY 11776 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-21 |
| Decision Date | 1995-02-23 |