JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor

Display, Diagnostic Radiology

Nanjing Jusha Display Technology Co., Ltd

The following data is part of a premarket notification filed by Nanjing Jusha Display Technology Co., Ltd with the FDA for Jusha-m550g/ Jusha-m550/m550g/m550 Lcd Monitor.

Pre-market Notification Details

Device IDK190848
510k NumberK190848
Device Name:JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
ClassificationDisplay, Diagnostic Radiology
Applicant Nanjing Jusha Display Technology Co., Ltd Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing,  CN 210036
ContactZilong Liang
CorrespondentZilong Liang
Nanjing Jusha Display Technology Co., Ltd Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing,  CN 210036
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-01
Decision Date2019-05-14
Summary:summary

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