FDA 510(k) Application Details - K242352

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K242352
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Accurate Meditech Inc. 8F-10, No.12, Ln.609, Sec.5, Chongxin Rd. New Taipei City 241406 TW Other 510(k) Applications for this Company
Contact	Kuan-Jen Wang 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	08/08/2024
Decision Date	02/05/2025
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