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FDA 510(k) Application Details - K163512
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K163512
Device Name
Detector And Alarm, Arrhythmia
Applicant
IRHYTHM TECHNOLOGIES, INC.
650 TOWNSEND STREET
SUITE 380
SAN FRANCISCO, CA 94103 US
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Contact
RICH LAGUNA
Other 510(k) Applications for this Contact
Regulation Number
870.1025
More FDA Info for this Regulation Number
Classification Product Code
DSI
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More FDA Info for this Product Code
Date Received
12/15/2016
Decision Date
06/02/2017
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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