Name: Predicase
Price: 199 USD

K-number	K210318
Device name	Apogee 6500,Apogee 6300,Apogee 6200 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 18, 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 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System

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