FDA 510(k) Application Details - K073376

Device Classification Name System, Ecg Analysis

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510(K) Number K073376
Device Name System, Ecg Analysis
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
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Contact PAUL SCHRADER
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Regulation Number 000.0000

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Classification Product Code LOS
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Date Received 12/03/2007
Decision Date 04/11/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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