Name: Predicase
Price: 199 USD

K-number	K233788
Device name	EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Applicant	Philips Ultrasound, LLC
Product code	IYN
Device class	Class II
Decision date	Feb 13, 2024
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

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