K-number	K191072
Device name	7410 Ultrasound System (MyLabSigma)
Applicant	Esaote, S.p.A.
Product code	IYN
Device class	Class II
Decision date	Jun 10, 2019
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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7410 Ultrasound System (MyLabSigma)

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