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FDA 510(k) Application Details - K124000
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K124000
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
MEDAPPS INC., DBA ALERE CONNECT
8767 E. VIA DE VENTURA, STE 300
SCOTTSDALE, AZ 85258 US
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Contact
KENT DICKS
Other 510(k) Applications for this Contact
Regulation Number
870.2910
More FDA Info for this Regulation Number
Classification Product Code
DRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2012
Decision Date
07/30/2013
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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