K-number	K213279
Device name	NovaGuide 2 Intelligent Ultrasound
Applicant	Novasignal Corporation
Product code	IYN
Device class	Class II
Decision date	Mar 2, 2022
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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NovaGuide 2 Intelligent Ultrasound

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