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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K073376
Device Name PHILIPS ECG ALGORITHM
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Applicant Contact PAUL SCHRADER
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Correspondent Contact PAUL SCHRADER
Classification Product Code
LOS
Subsequent Product Code
DPS  
Date Received12/03/2007
Decision Date 04/11/2008
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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