FDA 510(k) Application Details - K182626

Device Classification Name	More FDA Info for this Device
510(K) Number	K182626
Device Name	OEC One
Applicant	GE Hualun Medical Systems Co., Ltd. No.1 YongChang North Road, Beijing Economic Technological Development Zone Beijing 100176 CN Other 510(k) Applications for this Company
Contact	Lifeng Wang 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	09/24/2018
Decision Date	11/16/2018
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