FDA 510(k) Application Details - K033513

Device Classification Name Adaptor, Lead Switching, Electrocardiograph

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510(K) Number K033513
Device Name Adaptor, Lead Switching, Electrocardiograph
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
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Contact DAVID OSBORN
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Regulation Number 870.2350

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Classification Product Code DRW
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Date Received 11/06/2003
Decision Date 01/15/2004
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 N
Expedited Review



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