FDA 510(k) Application Details - K213282

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K213282
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	Energy Resources International Co., Ltd. Hsinchu Branch 2F-2, No. 6-1, Sec. 2, Zhengyi Rd Zhubei City 30261 TW Other 510(k) Applications for this Company
Contact	Nancy Liu 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	10/01/2021
Decision Date	04/04/2022
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