Hisense LCD Monitor HMD2C21A, HMD4C27S, HMD6C30D

Display, Diagnostic Radiology

Qingdao Hisense Medical Equipment Co., Ltd

The following data is part of a premarket notification filed by Qingdao Hisense Medical Equipment Co., Ltd with the FDA for Hisense Lcd Monitor Hmd2c21a, Hmd4c27s, Hmd6c30d.

Pre-market Notification Details

Device IDK222208
510k NumberK222208
Device Name:Hisense LCD Monitor HMD2C21A, HMD4C27S, HMD6C30D
ClassificationDisplay, Diagnostic Radiology
Applicant Qingdao Hisense Medical Equipment Co., Ltd No. 399 Songling Road, Laoshan District 266100, Qingdao, Shandong, P. R. China Qingdao,  CN 266100
ContactLu Zhonghao
CorrespondentLu Zhonghao
Qingdao Hisense Medical Equipment Co., Ltd No. 399 Songling Road, Laoshan District 266100, Qingdao, Shandong, P. R. China Qingdao,  CN 266100
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-25
Decision Date2022-11-17

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