FDA 510(k) Application Details - K233666

Device Classification Name	More FDA Info for this Device
510(K) Number	K233666
Device Name	CorVista System with PH Add-On
Applicant	Analytics for Life, Inc. 160 Bloor Street East Suite 910 Toronto M4W 1B9 CA Other 510(k) Applications for this Company
Contact	Gabrielle Zaeska Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2023
Decision Date	04/05/2024
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