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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 K190624
Device Name EarlyVue VS30
Applicant
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard Strasse 2
Boeblingen,  DE 71034
Applicant Contact Greg Li
Correspondent
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard Strasse 2
Boeblingen,  DE 71034
Correspondent Contact Greg Li
Regulation Number870.1100
Classification Product Code
DSJ  
Subsequent Product Codes
CCK   DQA   DSA   DSK   DXN  
FLL  
Date Received03/11/2019
Decision Date 10/27/2019
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
Recalls CDRH Recalls
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