Name: Predicase
Price: 199 USD

K-number	K201968
Device name	SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System
Applicant	CHISON Medical Technologies Co., Ltd.
Product code	IYN
Device class	Class II
Decision date	Feb 26, 2021
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System

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