FDA 510(k)

Augmento

Número K: K222781 · 2023-04-11

RequerenteDeeptek Medical Imaging Private Limited

Data da decisão2023-04-11

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Augmento is the device name listed in this FDA 510(k) record. The listed applicant is Deeptek Medical Imaging Private Limited. It received FDA 510(k) clearance on 2023-04-11 under 510(k) number K222781. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Augmento?

Augmento is a medical device that received FDA 510(k) clearance on 2023-04-11. The listed applicant is Deeptek Medical Imaging Private Limited. The 510(k) number is K222781.

When did Augmento receive FDA 510(k) clearance?

Augmento received FDA 510(k) clearance on 2023-04-11, under 510(k) number K222781.

Who is the listed applicant for Augmento?

The FDA 510(k) record lists Deeptek Medical Imaging Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Augmento?

The FDA product code for Augmento is LLZ.

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