FDA 510(k) Application Details - K223873

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K223873
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	PyrAmes Inc. 21730 Stevens Creek Blvd., Suite 201A Cupertino, CA 95014 US Other 510(k) Applications for this Company
Contact	Xina Quan 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	12/23/2022
Decision Date	09/29/2023
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