Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)

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 2mp/3mp Lcd Monitor (hmd2c21/hmd3c21).

Pre-market Notification Details

Device IDK152030
510k NumberK152030
Device Name:Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
ClassificationDisplay, Diagnostic Radiology
Applicant Qingdao Hisense Medical Equipment Co., Ltd. Software Outsourcing Center 3rd Floor North Wing No. 169 Songling Road, Laoshan Qing Dao,  CN 266101
ContactLiu Zhitang
CorrespondentLiu Zhitang
Qingdao Hisense Medical Equipment Co., Ltd. Software Outsourcing Center 3rd Floor North Wing No. 169 Songling Road, Laoshan Qing Dao,  CN 266101
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-22
Decision Date2015-09-16
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.