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FDA 510(k) Application Details - K130290
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K130290
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
INTEL-GE CARE INNOVATIONS LLC
3721 DOUGLAS BOULEVARD
SUITE 100
ROSEVILLE, CA 95661 US
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Contact
MAUREEN GLYNN
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
02/06/2013
Decision Date
06/04/2013
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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