MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY – HORIZON 9000 WS


Device Classification Name

computer, diagnostic, pre-programmed, single-function

510(k) Number K991775
Device Name MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY – HORIZON 9000 WS
Applicant
MENNEN MEDICAL, INC.
kiryat weizmann science park
p.o. box 102
rehovot, 

IL

76100

Applicant Contact kenneth raichman
Correspondent
MENNEN MEDICAL, INC.
kiryat weizmann science park
p.o. box 102
rehovot, 

IL

76100

Correspodent Contact kenneth raichman
Regulation Number 870.1435
Classification Product Code
DXG  
Date Received 05/25/1999
Decision Date 06/24/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No