FDA 510(k) Application Details - K221742

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K221742
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Atcor Medical No. 3 Jin Ping Street,Ya An Road, Nankai District Sydney 2000 AU Other 510(k) Applications for this Company
Contact	Toni Hofhine 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	06/15/2022
Decision Date	04/21/2023
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