FDA 510(k) Application Details - K181832

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K181832
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Guangdong Transtek Medical Electronics Co. Ltd Zone A, No 105 Dongli Road, Torch Development District Zhongshan 528437 CN Other 510(k) Applications for this Company
Contact	Nicole Hu 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	07/09/2018
Decision Date	04/09/2019
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