FDA 510(k) Application Details - DEN220063

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220063
Device Name	Caption Interpretation Automated Ejection Fraction Software
Applicant	Caption Health, Inc 2000 Sierra Point Parkway, 8th Floor Brisbane, CA 94005 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	QVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2022
Decision Date	02/24/2023
Decision	DENG -
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review