CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA


Device Classification Name

system, x-ray, angiographic

510(k) Number K073328
Device Name CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
Applicant
PAIEON, INC.
22 hamelacha st., p.o.b. 11355
rosh haayin, 

IL

48901

Applicant Contact ravit barkama
Correspondent
PAIEON, INC.
22 hamelacha st., p.o.b. 11355
rosh haayin, 

IL

48901

Correspodent Contact ravit barkama
Regulation Number 892.1600
Classification Product Code
IZI  
Date Received 11/27/2007
Decision Date 09/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No