FDA 510(k) Application Details - K130021

Device Classification Name	Automated Digital Image Manual Interpretation Microscope   More FDA Info for this Device
510(K) Number	K130021
Device Name	Automated Digital Image Manual Interpretation Microscope
Applicant	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 BEST, NB 5684 PC NL Other 510(k) Applications for this Company
Contact	DIRK VOSSEN Other 510(k) Applications for this Contact
Regulation Number	864.1860   More FDA Info for this Regulation Number
Classification Product Code	OEO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2013
Decision Date	09/19/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review