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FDA 510(k) Application Details - K171406
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K171406
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
United Health Group Inc.
1100 King Street, Buliding 6, Suite 300
Rye Brook, NY 10573 US
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Contact
Donald J. Matthews
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
05/12/2017
Decision Date
08/18/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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