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Leltek, Inc.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories1
Latest Approval2025-05-08
TypeNumberDevice NameCodeDate
510(k) K243226 Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) IYN 2025-05-08 View
510(k) K241161 Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging IYN 2024-09-11 View
510(k) K222365 Leltek Ultrasound Imaging System (Model: LU700 Series) IYN 2022-10-25 View
510(k) K210432 LELTEK Ultrasound Imaging System (Model: LU700 Series) IYN 2021-11-03 View
510(k) K191235 Leltek Ultrasound Imaging System IYN 2020-02-12 View
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