Name: Predicase
Price: 199 USD

K-number	K201316
Device name	Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
Applicant	Suzhou Peaksonic Medical Technology Co., Ltd.
Product code	IYO
Device class	Class II
Decision date	Feb 26, 2021
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)

Everything you need for a 510(k) submission. Nothing you don't.