FDA 510(k) Application Details - K131395

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K131395
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD NO.1 FANGHUA STREET, HI-TECH DISTRICT CHENGDU, SICHUAN 610041 CN Other 510(k) Applications for this Company
Contact	LEO WANG 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	05/15/2013
Decision Date	06/19/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review