FDA 510(k) Application Details - K061707

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K061707
Device Name Automated External Defibrillators (Non-Wearable)
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
M/S 0220
ANDOVER, MA 01810 US
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Contact SONGHUA ZHANG
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 06/16/2006
Decision Date 08/11/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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