FDA 510(k) Application Details - K192819

Device Classification Name	More FDA Info for this Device
510(K) Number	K192819
Device Name	OEC Elite
Applicant	GE OEC Medical Systems, Inc. 384 N Wright Brothers Drive Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Kenny M Bello 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	10/01/2019
Decision Date	11/08/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review