FDA 510(k) Application Details - K202891

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K202891
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	Endless Chan 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	09/28/2020
Decision Date	03/09/2021
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