FDA 510(k) Application Details - K193054

Device Classification Name	More FDA Info for this Device
510(K) Number	K193054
Device Name	Sectra Digital Pathology Module
Applicant	Sectra AB Teknikringen 20 Linkoping 58330 SE Other 510(k) Applications for this Company
Contact	Edoardo Mastrovito 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	11/01/2019
Decision Date	03/31/2020
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