Leltek Ultrasound Imaging System
K-Number: K191235 · 2020-02-12
ApplicantLeltek, Inc.
Decision Date2020-02-12
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Leltek Ultrasound Imaging System is a medical device manufactured by Leltek, Inc.. It received FDA 510(k) clearance on 2020-02-12 under approval number K191235. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Leltek Ultrasound Imaging System?
Leltek Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2020-02-12. It is manufactured by Leltek, Inc.. The 510(k) number is K191235.
When was Leltek Ultrasound Imaging System approved by the FDA?
Leltek Ultrasound Imaging System received FDA 510(k) clearance on 2020-02-12, under approval number K191235.
What company makes Leltek Ultrasound Imaging System?
Leltek Ultrasound Imaging System is manufactured by Leltek, Inc..
What is the FDA product code for Leltek Ultrasound Imaging System?
The FDA product code for Leltek Ultrasound Imaging System is IYN.
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Other Devices by Leltek, Inc.
K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)
K222365Leltek Ultrasound Imaging System (Model: LU700 Series)
K241161Ultrasound 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
K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.