FDA 510(k) Application Details - K201992

Device Classification Name	More FDA Info for this Device
510(K) Number	K201992
Device Name	Caption Guidance
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	QJU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2020
Decision Date	09/18/2020
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