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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K101521
Device Name ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
Applicant
Philips Medical Systems
3000 Minuteman Rd., Ms 0480
Andover,  MA  01810
Applicant Contact LOIS GIEGERICH
Correspondent
Philips Medical Systems
3000 Minuteman Rd., Ms 0480
Andover,  MA  01810
Correspondent Contact LOIS GIEGERICH
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DSI   MLD  
Date Received06/02/2010
Decision Date 07/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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