K-number	K210432
Device name	LELTEK Ultrasound Imaging System (Model: LU700 Series)
Applicant	Leltek, Inc.
Product code	IYN
Device class	Class II
Decision date	Nov 3, 2021
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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LELTEK Ultrasound Imaging System (Model: LU700 Series)

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