FDA 510(k) Application Details - K243065

Device Classification Name	More FDA Info for this Device
510(K) Number	K243065
Device Name	Cardiac Guidance
Applicant	Caption Health, Inc. 4 West 4th Avenue Suite 215 San Mateo, CA 94402 US Other 510(k) Applications for this Company
Contact	Tahir Rizvi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2024
Decision Date	01/15/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review