FDA 510(k) Application Details - K041459

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K041459
Device Name Automated External Defibrillators (Non-Wearable)
Applicant MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
11811 WILLOWS RD., N.E.
REDMOND, WA 98073 US
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Contact MICHELLE ACKERMANN
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 06/02/2004
Decision Date 07/01/2004
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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