FDA 510(k) Application Details - K191864

Device Classification Name	More FDA Info for this Device
510(K) Number	K191864
Device Name	21HK512D
Applicant	LG Electronics Inc. 222, LG-ro, Cheongho-ri, Jinwi-myeon Pyeongtaek-si 17709 KR Other 510(k) Applications for this Company
Contact	Jinhwan Jun Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2019
Decision Date	12/05/2019
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