FDA 510(k)

Leltek Ultrasound Imaging System

N.º K: K191235 · 2020-02-12

Fecha de decisión2020-02-12

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Leltek Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Leltek, Inc.. It received FDA 510(k) clearance on 2020-02-12 under 510(k) number K191235. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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. The listed applicant is Leltek, Inc.. The 510(k) number is K191235.

When did Leltek Ultrasound Imaging System receive FDA 510(k) clearance?

Leltek Ultrasound Imaging System received FDA 510(k) clearance on 2020-02-12, under 510(k) number K191235.

Who is the listed applicant for Leltek Ultrasound Imaging System?

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?

The FDA product code for Leltek Ultrasound Imaging System is IYN.

Ensayos clínicos relacionados

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Otros registros que enlistan a Leltek, Inc. como solicitante

Dispositivos relacionados (Código: IYN)

Fuente oficial

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