FDA 510(k) Application Details - K002232

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K002232
Device Name Automated External Defibrillators (Non-Wearable)
Applicant MEDICAL RESEARCH LABORATORIES, INC.
1000 ASBURY DR. NO.17
BUFFALO GROVE, IL 60089 US
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Contact JOEL ORLINSKY
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 07/24/2000
Decision Date 12/06/2000
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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