FDA 510(k) Application Details - K200905

Device Classification Name	More FDA Info for this Device
510(K) Number	K200905
Device Name	HealthMammo
Applicant	Zebra Medical Vision Ltd. Shefayim Commercial Center, PO Box 25 Shefayim 6099000 IL Other 510(k) Applications for this Company
Contact	Flair Bar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2020
Decision Date	07/16/2020
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