FDA 510(k) Application Details - K193628

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K193628
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Dongguan E-Test Technology Co., Ltd Room 201, 301. Building 1, Changping Section No.1, Dongshen Road Dongguan 523588 CN Other 510(k) Applications for this Company
Contact	Victor Wan 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	12/26/2019
Decision Date	07/12/2020
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