FDA 510(k) Application Details - K013425

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K013425
Device Name Automated External Defibrillators (Non-Wearable)
Applicant PHILIPS MEDICAL SYSTEMS
2401 FOURTH AVE., SUITE 500
SEATTLE, WA 98121 US
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Contact TAMARA YOUNT
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 10/16/2001
Decision Date 01/14/2002
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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