THE CARDIOP-B SYSTEM


Device Classification Name

system, x-ray, angiographic

510(k) Number K030139
Device Name THE CARDIOP-B SYSTEM
Original Applicant
PAIEON, INC.
747 third ave., 4th floor
new york, 
NY 
10017 -2803

Original Contact omer barlev
Regulation Number 892.1600
Classification Product Code
IZI  
Date Received 01/14/2003
Decision Date 04/02/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No