FDA 510(k) Application Details - K250968

Device Classification Name	More FDA Info for this Device
510(K) Number	K250968
Device Name	PathPresenter Clinical Viewer
Applicant	PathPresenter Corporation 19 Louis Drive Montville, NJ 07045 US Other 510(k) Applications for this Company
Contact	Brian Matcheski 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	03/31/2025
Decision Date	06/20/2025
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