FDA 510(k) Application Details - K111914

Device Classification Name	Automated Digital Image Manual Interpretation Microscope   More FDA Info for this Device
510(K) Number	K111914
Device Name	Automated Digital Image Manual Interpretation Microscope
Applicant	OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP 3500 CORPORATE PARKWAY P.O. BOX 610 CENTER VALLEY, PA 18034-0610 US Other 510(k) Applications for this Company
Contact	SHERI L MUSGNUNG 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	07/06/2011
Decision Date	08/21/2012
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