ST80I STRESS TEST SYSTEM


Device Classification Name

computer, diagnostic, programmable

510(k) Number K121638
Device Name ST80I STRESS TEST SYSTEM
Applicant
PHILIPS HEALTHCARE
1525 rancho conejo blvd
suite 100
thousand oaks, 
CA 
91320

Applicant Contact gretal lumley
Correspondent
PHILIPS HEALTHCARE
1525 rancho conejo blvd
suite 100
thousand oaks, 
CA 
91320

Correspodent Contact gretal lumley
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 06/04/2012
Decision Date 07/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No