FDA 510(k) Application Details - K133781

Device Classification Name	Probe, Uptake, Nuclear   More FDA Info for this Device
510(K) Number	K133781
Device Name	Probe, Uptake, Nuclear
Applicant	SURGICEYE GMBH FRIEDENSTRASSE 18A MUNICH, BAVARIA 81671 DE Other 510(k) Applications for this Company
Contact	MORITZ HOYER Other 510(k) Applications for this Contact
Regulation Number	892.1320   More FDA Info for this Regulation Number
Classification Product Code	IZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2013
Decision Date	04/11/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review