Name: Predicase
Price: 199 USD

K-number	K183041
Device name	Full Digital Colour Doppler Ultrasonic Diagnostic System
Applicant	Wuhan Zoncare Bio-medical Electronics Co., Ltd.
Product code	IYN
Device class	Class II
Decision date	Jul 10, 2019
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Full Digital Colour Doppler Ultrasonic Diagnostic System

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