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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K121638
Device Name ST80I STRESS TEST SYSTEM
Applicant
Philips Health Care
1525 Rancho Conejo Blvd.
Suite 100
Thousand Oaks,  CA  91320
Applicant Contact GRETAL LUMLEY
Correspondent
Philips Health Care
1525 Rancho Conejo Blvd.
Suite 100
Thousand Oaks,  CA  91320
Correspondent Contact GRETAL LUMLEY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/04/2012
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
Predetermined Change
Control Plan Authorized		 No
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