FDA 510(k) Application Details - K113085

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K113085
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	TRULY INSTRUMENT CO., LTD. 2620 CONCORD AVENUE SUITE 106 ALHAMBRA, CA 91803 US Other 510(k) Applications for this Company
Contact	MAX WONG Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2011
Decision Date	01/12/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review