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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 K163649
Device Name SureSigns VS3; SureSigns VS4
Applicant
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Greg Li
Correspondent
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Greg Li
Regulation Number870.1100
Classification Product Code
DSJ  
Subsequent Product Codes
CCK   DQA   DSA   DSK   DXN  
FLL  
Date Received12/23/2016
Decision Date 03/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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