FDA 510(k) Application Details - K222208

Device Classification Name	More FDA Info for this Device
510(K) Number	K222208
Device Name	Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
Applicant	Qingdao Hisense Medical Equipment Co., Ltd No. 399 Songling Road, Laoshan District 266100, Qingdao, Shandong, P. R. China Qingdao 266100 CN Other 510(k) Applications for this Company
Contact	Lu Zhonghao Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/2022
Decision Date	11/17/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review