FDA 510(k) Application Details - K190507

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K190507
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Health & Life Co. ltd. 9F, No. 186 Jian Yi Road Zhonghe District, New Taipei City 23553 TW Other 510(k) Applications for this Company
Contact	J.S. Hsu 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	03/01/2019
Decision Date	09/16/2019
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