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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 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,  CN 266100
Applicant Contact Lu Zhonghao
Correspondent
Qingdao Hisense Medical Equipment Co., Ltd
No. 399 Songling Road, Laoshan District
266100, Qingdao, Shandong, P. R. China
Qingdao,  CN 266100
Correspondent Contact Lu Zhonghao
Regulation Number892.2050
Classification Product Code
PGY  
Date Received07/25/2022
Decision Date 11/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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