FDA 510(k) Application Details - K030417

Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)

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510(K) Number K030417
Device Name Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
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Contact PETER OHANIAN
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Regulation Number 870.5300

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Classification Product Code LDD
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Date Received 02/10/2003
Decision Date 05/09/2003
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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