CPCA2000 COUNTERPULSATION SYSTEM


Device Classification Name

device, counter-pulsating, external

510(k) Number K030532
Device Name CPCA2000 COUNTERPULSATION SYSTEM
Applicant
CPCA2000 INC
6336 17th st. circle east
sarasota, 
FL 
34243

Applicant Contact rod shipman
Correspondent
CPCA2000 INC
6336 17th st. circle east
sarasota, 
FL 
34243

Correspodent Contact rod shipman
Regulation Number 870.5225
Classification Product Code
DRN  
Date Received 02/19/2003
Decision Date 03/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No