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FDA 510(k)

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)

N.º K: K233401 · 2024-02-12

SolicitanteEieling Technology Limited
Fecha de decisión2024-02-12
Código de productoIYO
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) is the device name listed in this FDA 510(k) record. The listed applicant is Eieling Technology Limited. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233401. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)?

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Eieling Technology Limited. The 510(k) number is K233401.

When did Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) receive FDA 510(k) clearance?

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233401.

Who is the listed applicant for Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)?

The FDA 510(k) record lists Eieling Technology Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)?

The FDA product code for Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) is IYO.

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Fuente oficial

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