FDA 510(k) Application Details - K201914

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K201914
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Taiwan Scientific Corporation 10F, 88-4, Ming-Chiuan Rd., Shin-Dian District New Taipei 23141 TW Other 510(k) Applications for this Company
Contact	D.C. Sun 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	07/09/2020
Decision Date	06/07/2021
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