FDA 510(k)

LELTEK Ultrasound Imaging System (Model: LU700 Series)

Número K: K210432 · 2021-11-03

Data da decisão2021-11-03

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

LELTEK Ultrasound Imaging System (Model: LU700 Series) is the device name listed in this FDA 510(k) record. The listed applicant is Leltek, Inc.. It received FDA 510(k) clearance on 2021-11-03 under 510(k) number K210432. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LELTEK Ultrasound Imaging System (Model: LU700 Series)?

LELTEK Ultrasound Imaging System (Model: LU700 Series) is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is Leltek, Inc.. The 510(k) number is K210432.

When did LELTEK Ultrasound Imaging System (Model: LU700 Series) receive FDA 510(k) clearance?

LELTEK Ultrasound Imaging System (Model: LU700 Series) received FDA 510(k) clearance on 2021-11-03, under 510(k) number K210432.

Who is the listed applicant for LELTEK Ultrasound Imaging System (Model: LU700 Series)?

The FDA 510(k) record lists Leltek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LELTEK Ultrasound Imaging System (Model: LU700 Series)?

The FDA product code for LELTEK Ultrasound Imaging System (Model: LU700 Series) is IYN.

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