FDA 510(k)

Cornisol

Número K: K221759 · 2022-10-05

Data da decisão2022-10-05

Código do produtoLYX

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cornisol is the device name listed in this FDA 510(k) record. The listed applicant is Aurolab. It received FDA 510(k) clearance on 2022-10-05 under 510(k) number K221759. The device is classified under product code LYX. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cornisol?

Cornisol is a medical device that received FDA 510(k) clearance on 2022-10-05. The listed applicant is Aurolab. The 510(k) number is K221759.

When did Cornisol receive FDA 510(k) clearance?

Cornisol received FDA 510(k) clearance on 2022-10-05, under 510(k) number K221759.

Who is the listed applicant for Cornisol?

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

What is the FDA product code for Cornisol?

The FDA product code for Cornisol is LYX.

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