FDA 510(k) Application Details - K002280

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K002280
Device Name Automated External Defibrillators (Non-Wearable)
Applicant MEDICAL DEVICES, INC.
2500 BELL AVE.
DES MOINES, IA 50321 US
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Contact WARREN R WALTERS
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 07/26/2000
Decision Date 02/05/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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