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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alarm, Blood-Pressure
510(k) Number K151761
Device Name SureSigns VS3, SureSigns VS4
Applicant
Phillips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Greg Li
Correspondent
Phillips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Greg Li
Regulation Number870.1100
Classification Product Code
DSJ  
Subsequent Product Codes
CCK   DSK   FLL  
Date Received06/29/2015
Decision Date 09/29/2015
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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