FDA 510(k) Application Details - K062233

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K062233
Device Name Automated External Defibrillators (Non-Wearable)
Applicant PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
3000 MINUTEMAN ROAD
ANDOVER, MA 01810-1099 US
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Contact MICHAEL J DOYLE
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 08/02/2006
Decision Date 11/22/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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