FDA 510(k) Application Details - K201005

Device Classification Name	More FDA Info for this Device
510(K) Number	K201005
Device Name	FullFocus
Applicant	Paige.AI, Inc 11 Times Square, 37th Floor New York, NY 10036 US Other 510(k) Applications for this Company
Contact	Jillian Sue Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2020
Decision Date	07/15/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review