FDA 510(k) Application Details - K240759

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K240759
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	Remedi Co., Ltd. 69-14, Sakju-ro 145beon-gil Chuncheon-si, Gangwon-do Seoul 24232 KR Other 510(k) Applications for this Company
Contact	Sungho Cho Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	EHD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2024
Decision Date	05/13/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review