SR-8230, SR-8230S Portable X-ray Unit

System, X-ray, Mobile

Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI)

The following data is part of a premarket notification filed by Shantou Institute Of Ultrasonic Instruments Co., Ltd. (siui) with the FDA for Sr-8230, Sr-8230s Portable X-ray Unit.

Pre-market Notification Details

Device IDK200976
510k NumberK200976
Device Name:SR-8230, SR-8230S Portable X-ray Unit
ClassificationSystem, X-ray, Mobile
Applicant Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road Shantou,  CN 515041
ContactFlower Cai
CorrespondentFlower Cai
Shantou Institute Of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road Shantou,  CN 515041
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-13
Decision Date2020-06-10

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