FDA 510(k)

trophon2

Número K: K250434 · 2025-08-05

Data da decisão2025-08-05

Código do produtoOUJ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

trophon2 is the device name listed in this FDA 510(k) record. The listed applicant is Nanosonics. It received FDA 510(k) clearance on 2025-08-05 under 510(k) number K250434. The device is classified under product code OUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the trophon2?

trophon2 is a medical device that received FDA 510(k) clearance on 2025-08-05. The listed applicant is Nanosonics. The 510(k) number is K250434.

When did trophon2 receive FDA 510(k) clearance?

trophon2 received FDA 510(k) clearance on 2025-08-05, under 510(k) number K250434.

Who is the listed applicant for trophon2?

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

What is the FDA product code for trophon2?

The FDA product code for trophon2 is OUJ.

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Dispositivos Relacionados (Código: OUJ)

K241536trophon Wireless Ultrasound Probe HolderNanosonics Limited K173865trophon2Nanosonics Limited

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