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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph
510(k) Number K132068
Device Name PHILIPS DXL 12/16-LEAD ECG ALGORITHM
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD
ANDOVER,  MA  01810
Applicant Contact THERESA POOLE
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD
ANDOVER,  MA  01810
Correspondent Contact THERESA POOLE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/03/2013
Decision Date 09/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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