SR-8100 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-8100 Portable X-ray Unit.

Pre-market Notification Details

Device IDK200637
510k NumberK200637
Device Name:SR-8100 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 Received2020-03-10
Decision Date2020-07-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06938396481018 K200637 000
06938396481001 K200637 000
06938396480059 K200637 000
06938396480042 K200637 000

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