Name: Predicase
Price: 199 USD

K-number	K173000
Device name	Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
Applicant	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Product code	IYN
Device class	Class II
Decision date	Dec 7, 2017
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System

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