EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP


Device Classification Name

device, counter-pulsating, external

510(k) Number K030587
Device Name EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP
Applicant
S-TCT HEALTH INC.
2020 ponce de leon blvd., suite 1101
coral gables, 
FL 
33134

Applicant Contact katherine l giannamore
Correspondent
S-TCT HEALTH INC.
2020 ponce de leon blvd., suite 1101
coral gables, 
FL 
33134

Correspodent Contact katherine l giannamore
Regulation Number 870.5225
Classification Product Code
DRN  
Date Received 02/25/2003
Decision Date 05/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No