FDA 510(k) Application Details - K993533

Device Classification Name Automated External Defibrillators (Non-Wearable)

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510(K) Number K993533
Device Name Automated External Defibrillators (Non-Wearable)
Applicant CARDIAC SCIENCE, INC.
16931 MILLIKAN AVE.
IRVINE, CA 92606 US
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Contact STAN E TILLMAN
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Regulation Number 870.5310

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Classification Product Code MKJ
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Date Received 10/19/1999
Decision Date 01/24/2000
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Special
Reviewed By Third Party N
Expedited Review



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