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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 K151812
Device Name PATIENT MONITORS VARIOUS MODELS
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN ROAD
ANDOVER,  MA  03104 -1099
Applicant Contact MARY KRUITWAGEN
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN ROAD
ANDOVER,  MA  03104 -1099
Correspondent Contact MARY KRUITWAGEN
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DXQ  
Date Received07/02/2015
Decision Date 01/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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