VENDYS, MODEL 6000 B B/C


Device Classification Name

computer, diagnostic, programmable

510(k) Number K072919
Device Name VENDYS, MODEL 6000 B B/C
Applicant
ENDOTHELIX, INC.
8275 el rio
suite 100
houston, 
TX 
77054

Applicant Contact doug blakely
Correspondent
ENDOTHELIX, INC.
8275 el rio
suite 100
houston, 
TX 
77054

Correspodent Contact doug blakely
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 10/15/2007
Decision Date 11/02/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No