FDA 510(k) Application Details - K231335

Device Classification Name	More FDA Info for this Device
510(K) Number	K231335
Device Name	Cleerly ISCHEMIA
Applicant	Cleerly, Inc 110 16th Steet Suite 1400 #104 Denver, CO 80218 US Other 510(k) Applications for this Company
Contact	Candice Bautista-Biddle Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2023
Decision Date	09/08/2023
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