FDA 510(k) Application Details - K003819

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K003819
Device Name Automated External Defibrillators (Non-Wearable)
Applicant AGILENT TECHNOLOGIES, INC.
2401 FOURTH AVE., SUITE 500
SEATTLE, WA 98121 US
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Contact TERESA SKARR
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 12/11/2000
Decision Date 05/02/2001
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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