K-number	K221270
Device name	EchoNavigator R4.0
Applicant	Philips Medical Systems Nederland B.V.
Product code	LLZ
Device class	Class II
Decision date	May 31, 2022
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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EchoNavigator R4.0

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