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FDA 510(k) Application Details - K161916
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K161916
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
MEDICOMP, INC.
600 ATLANTIS RD
MELBOURNE, FL 32904 US
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Contact
Sean Marcus
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
07/12/2016
Decision Date
12/21/2016
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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