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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 K172226
Device Name MX40 Release B.07
Applicant
Philips Medical Systems
3000 Minuteman Road
Andover,  MA  01810
Applicant Contact Theresa Poole
Correspondent
Philips Medical Systems
3000 Minuteman Road
Andover,  MA  01810
Correspondent Contact Theresa Poole
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DRG   DRW   DSA   DSI  
MLD   MSX  
Date Received07/25/2017
Decision Date 11/09/2017
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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