FDA 510(k)

Idys® LIF

Número K: K243670 · 2024-12-31

Data da decisão2024-12-31

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Idys® LIF is the device name listed in this FDA 510(k) record. The listed applicant is Clariance. It received FDA 510(k) clearance on 2024-12-31 under 510(k) number K243670. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Idys® LIF?

Idys® LIF is a medical device that received FDA 510(k) clearance on 2024-12-31. The listed applicant is Clariance. The 510(k) number is K243670.

When did Idys® LIF receive FDA 510(k) clearance?

Idys® LIF received FDA 510(k) clearance on 2024-12-31, under 510(k) number K243670.

Who is the listed applicant for Idys® LIF?

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

What is the FDA product code for Idys® LIF?

The FDA product code for Idys® LIF is MAX.

Outros registros que listam Clariance como candidato(a)

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Fonte oficial

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