FDA 510(k) Application Details - K113144

Device Classification Name Electrocardiograph

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510(K) Number K113144
Device Name Electrocardiograph
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 870.2340

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Classification Product Code DPS
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Date Received 10/25/2011
Decision Date 04/03/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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