FDA 510(k) Application Details - K233914

Device Classification Name	Unit, X-Ray, Extraoral With Timer   More FDA Info for this Device
510(K) Number	K233914
Device Name	Unit, X-Ray, Extraoral With Timer
Applicant	Shenzhen Xpectvision Technology Co., Ltd. B507,Block A&B,Nanshan Medical Device Industrial Park,Nanhai Avenue 1019,Nanshan District,1st Floor, Building A31 No.44 Xiangrui 3rd Road, Nanshan Distric 518000 CN Other 510(k) Applications for this Company
Contact	Silver Cai 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	12/12/2023
Decision Date	02/08/2024
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