FDA 510(k) Application Details - K221008

Device Classification Name	System,X-Ray,Extraoral Source,Digital   More FDA Info for this Device
510(K) Number	K221008
Device Name	System,X-Ray,Extraoral Source,Digital
Applicant	Shanghai Handy Medical Equipment Co., Ltd Floor 2, Building No. 11, Lane177, Fulian Er Road Baoshan District 201906 CN Other 510(k) Applications for this Company
Contact	Marcia 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	04/05/2022
Decision Date	06/22/2022
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