FDA 510(k)

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber

N.º K: K240569 · 2024-11-21

Fecha de decisión2024-11-21

Código de productoCBF

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber is the device name listed in this FDA 510(k) record. The listed applicant is Fink Engineering Pty, Ltd.. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K240569. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber?

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is Fink Engineering Pty, Ltd.. The 510(k) number is K240569.

When did FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber receive FDA 510(k) clearance?

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber received FDA 510(k) clearance on 2024-11-21, under 510(k) number K240569.

Who is the listed applicant for FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber?

The FDA 510(k) record lists Fink Engineering Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber?

The FDA product code for FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber is CBF.

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Fuente oficial

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