FDA 510(k) Application Details - K190982

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K190982
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Xiamen Ants Bro Technology Co., Ltd. 4th & 5th Floor, No.5 Building, Tech & Innovation Center No. 289 Wengjiao Road Xiamen 361026 CN Other 510(k) Applications for this Company
Contact	Jane Xu 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	04/15/2019
Decision Date	05/29/2020
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