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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
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 N. Wing,
#169 Songling Rd., Laoshan
Qing Dao,  CN 266101
Applicant Contact Liu zhitang
Correspondent
Qingdao Hisense Medical Equipment Co., Ltd.
Software Outsourcing Center 3rd Floor N. Wing,
#169 Songling Rd., Laoshan
Qing Dao,  CN 266101
Correspondent Contact Liu zhitang
Regulation Number892.2050
Classification Product Code
PGY  
Date Received02/08/2016
Decision Date 03/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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