K-number	K213488
Device name	Bladder Scanner, Model Name:M5
Applicant	Suzhou Peaksonic Medical Technology Co., Ltd.
Product code	IYO
Device class	Class II
Decision date	Jul 1, 2022
Decision	Substantially Equivalent
Regulation	892.1560

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View the full FDA submission: accessdata.fda.gov

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Bladder Scanner, Model Name:M5

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