Name: Predicase
Price: 199 USD

K-number	K200136
Device name	Shear Wave Quantificational Ultrasound Diagnostic System
Applicant	Wuxi Hisky Medical Technologies Co., Ltd.
Product code	IYO
Device class	Class II
Decision date	Mar 17, 2020
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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Shear Wave Quantificational Ultrasound Diagnostic System

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