FDA 510(k)

DEKA Loop

Número K: K234055 · 2024-03-13

Data da decisão2024-03-13

Código do produtoQJI

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

DEKA Loop is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2024-03-13 under 510(k) number K234055. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DEKA Loop?

DEKA Loop is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Deka Research and Development. The 510(k) number is K234055.

When did DEKA Loop receive FDA 510(k) clearance?

DEKA Loop received FDA 510(k) clearance on 2024-03-13, under 510(k) number K234055.

Who is the listed applicant for DEKA Loop?

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

What is the FDA product code for DEKA Loop?

The FDA product code for DEKA Loop is QJI.

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Fonte oficial

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