FDA 510(k) Application Details - K130676

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K130676
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH 1266 EAST MAIN STREET SUITE 700R STAMFORD, CT 06902 US Other 510(k) Applications for this Company
Contact	KEVIN JONES 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	03/12/2013
Decision Date	07/08/2013
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