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FDA 510(k) Application Details - K122758
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K122758
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
CARDIAC SCIENCE CORPORATION
N7 W22025 Johnson Dr
--
Waukesha, WI 53186 US
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Contact
KATHLEEN ROBERTS
Other 510(k) Applications for this Contact
Regulation Number
870.5310
More FDA Info for this Regulation Number
Classification Product Code
MKJ
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More FDA Info for this Product Code
Date Received
09/10/2012
Decision Date
02/12/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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