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FDA 510(k) Application Details - K150117
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K150117
Device Name
Detector And Alarm, Arrhythmia
Applicant
Medtronic, Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112 US
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Contact
Eric Kalmes
Other 510(k) Applications for this Contact
Regulation Number
870.1025
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Classification Product Code
DSI
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More FDA Info for this Product Code
Date Received
01/20/2015
Decision Date
05/27/2015
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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