JUSHA-M32 MEDICAL DISPLAY

System, Image Processing, Radiological

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-m32 Medical Display.

Pre-market Notification Details

Device IDK131391
510k NumberK131391
Device Name:JUSHA-M32 MEDICAL DISPLAY
ClassificationSystem, Image Processing, Radiological
Applicant NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD 7TH FLOOR, 982. CONGYUN RD. BAIYUN DISTRICT Guangzhou, Guangdong,  CN Ch510420
ContactMike Gu
CorrespondentMike Gu
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD 7TH FLOOR, 982. CONGYUN RD. BAIYUN DISTRICT Guangzhou, Guangdong,  CN Ch510420
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-14
Decision Date2013-08-21
Summary:summary

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