HORIZON XVU


Device Classification Name

computer, diagnostic, programmable

510(k) Number K081484
Device Name HORIZON XVU
Applicant
MENNEN MEDICAL LTD.
4 hayarden st., yavne
p.o.box 102
rehovot, 

IL

76100

Applicant Contact ifat oren
Correspondent
MENNEN MEDICAL LTD.
4 hayarden st., yavne
p.o.box 102
rehovot, 

IL

76100

Correspodent Contact ifat oren
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 05/28/2008
Decision Date 06/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No