FDA 510(k) Application Details - K202757

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K202757
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Contec Medical Systems Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone Hebei Province 066004 CN Other 510(k) Applications for this Company
Contact	Xueyong Li 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	09/21/2020
Decision Date	04/28/2021
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