FDA 510(k) Application Details - K172550

Device Classification Name	More FDA Info for this Device
510(K) Number	K172550
Device Name	OEC Elite
Applicant	GE OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Rachel Schandel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2017
Decision Date	11/16/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review