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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
Other 510(k) Applications for this Contact
Regulation Number
870.5310
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Classification Product Code
MKJ
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More FDA Info for this Product Code
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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