FDA 510(k) Application Details - K161886

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K161886
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD ZONE B, No.105, DONGLI ROAD, TORCH DEVELOPMENT DISTRICT ZHONGSHAN 528437 CN Other 510(k) Applications for this Company
Contact	ADA ZHANG 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	07/11/2016
Decision Date	10/14/2016
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