Name: Predicase
Price: 199 USD

K-number	K190186
Device name	Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System
Applicant	Edan Instruments, Inc.
Product code	IYO
Device class	Class II
Decision date	Mar 28, 2019
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System

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