FDA 510(k) Application Details - K221587

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K221587
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	DIGIMED Co., Ltd. 145, Gasan digital 1-ro, Geumcheon-gu Seoul 08506 KR Other 510(k) Applications for this Company
Contact	Youngbae Kwon 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	06/01/2022
Decision Date	03/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review