FDA 510(k) Application Details - K160347

Device Classification Name	More FDA Info for this Device
510(K) Number	K160347
Device Name	Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
Applicant	QINGDAO HISENSE MEDICAL EQUIPMENT CO.,LTD Software outsourcing center 3rd floor north wing, No.169 Songling Road, Laoshan Qing dao 266101 CN Other 510(k) Applications for this Company
Contact	Liu zhitang 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	02/08/2016
Decision Date	03/03/2016
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