K-number	K200637
Device name	SR-8100 Portable X-ray Unit
Applicant	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Product code	IZL
Device class	Class II
Decision date	Jul 9, 2020
Decision	Substantially Equivalent
Regulation	892.1720

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View the full FDA submission: accessdata.fda.gov

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SR-8100 Portable X-ray Unit

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