FDA 510(k) Application Details - K192259

Device Classification Name	More FDA Info for this Device
510(K) Number	K192259
Device Name	Philips IntelliSite Pathology Solution
Applicant	Philips Electronics Nederland B.V. Veenpluis 6 Best 5684 PC NL Other 510(k) Applications for this Company
Contact	Liselotte Kornmann Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2019
Decision Date	09/20/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review