K-number	K191792
Device name	Versana Balance
Applicant	GE Medical Systems Ultrasound and Primary Care Diagnostics
Product code	IYN
Device class	Class II
Decision date	Aug 9, 2019
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Versana Balance

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