The following data is part of a premarket notification filed by Endothelix, Inc. with the FDA for Vendys, Model 6000 B B/c.
| Device ID | K072919 |
| 510k Number | K072919 |
| Device Name: | VENDYS, MODEL 6000 B B/C |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ENDOTHELIX, INC. 8275 EL RIO SUITE 100 Houston, TX 77054 |
| Contact | Doug Blakely |
| Correspondent | Doug Blakely ENDOTHELIX, INC. 8275 EL RIO SUITE 100 Houston, TX 77054 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-15 |
| Decision Date | 2007-11-02 |