Name: Predicase
Price: 199 USD

K-number	K201965
Device name	SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
Applicant	CHISON Medical Technologies Co., Ltd.
Product code	IYN
Device class	Class II
Decision date	Mar 2, 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 P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System

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