FDA 510(k) Application Details - K191614

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K191614
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	BioIntelliSense Inc. 570 El Camino Real, Suite 200 Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	Henry Leung 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	06/18/2019
Decision Date	12/18/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review