FDA 510(k) Application Details - K214091

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K214091
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	Hefei DentaFilm Medical Equipment Co., Ltd No. 98 Tangkou Road, Economic and Technological Development Zone Hefei 230601 CN Other 510(k) Applications for this Company
Contact	Ming Chang Qiu Other 510(k) Applications for this Contact
Regulation Number	872.1800   More FDA Info for this Regulation Number
Classification Product Code	MUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2021
Decision Date	03/02/2022
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