The following data is part of a premarket notification filed by Endothelix, Inc. with the FDA for Vendys Model 5000 B/bc.
| Device ID | K060980 |
| 510k Number | K060980 |
| Device Name: | VENDYS MODEL 5000 B/BC |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ENDOTHELIX, INC. 2472 BOLSOVER SUITE 439C Houston, TX 77005 |
| Contact | Douglas Blakely |
| Correspondent | Douglas Blakely ENDOTHELIX, INC. 2472 BOLSOVER SUITE 439C Houston, TX 77005 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-10 |
| Decision Date | 2007-08-16 |
| Summary: | summary |