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FDA 510(k) Application Details - K171019
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K171019
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
Synergen Technology Labs LLC
3131 McKinney Avenue
Suite 602
Dallas, TX 75204 US
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Contact
Sunil Konda
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
04/05/2017
Decision Date
05/30/2018
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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