FDA 510(k)

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)

Número K: K242496 · 2024-11-19

RequerenteEieling Technology (Shenzhen) Limited

Data da decisão2024-11-19

Código do produtoIYO

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) is the device name listed in this FDA 510(k) record. The listed applicant is Eieling Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2024-11-19 under 510(k) number K242496. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) is a medical device that received FDA 510(k) clearance on 2024-11-19. The listed applicant is Eieling Technology (Shenzhen) Limited. The 510(k) number is K242496.

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

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) received FDA 510(k) clearance on 2024-11-19, under 510(k) number K242496.

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

The FDA 510(k) record lists Eieling Technology (Shenzhen) 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 C)?

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

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Fonte oficial

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