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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
Other 510(k) Applications for this Contact
Regulation Number
870.5310
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Classification Product Code
MKJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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