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FDA 510(k) Application Details - K132930
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K132930
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
ENTRA HEALTH SYSTEMS
3111 Camino Del Rio North
Suite 101
San Diego, CA 92108 US
Other 510(k) Applications for this Company
Contact
RICHARD STROBRIDGE
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
09/18/2013
Decision Date
04/14/2014
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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