Name: Predicase
Price: 199 USD

K-number	K201971
Device name	SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
Applicant	CHISON Medical Technologies Co., Ltd.
Product code	IYN
Device class	Class II
Decision date	Feb 25, 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 P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System

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