FDA 510(k) Application Details - K200621

Device Classification Name	More FDA Info for this Device
510(K) Number	K200621
Device Name	Caption Interpretation Automated Ejection Fraction Software
Applicant	Caption Health 2000 Sierra Point Pkwy Brisbane, CA 94005 US Other 510(k) Applications for this Company
Contact	Sam Surette Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/2020
Decision Date	07/22/2020
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