Name: Predicase
Price: 199 USD

K-number	K210317
Device name	Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System
Applicant	Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Product code	IYN
Device class	Class II
Decision date	Aug 19, 2021
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System

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