FDA 510(k)

ON3D

Número K: K221000 · 2022-05-23

Data da decisão2022-05-23

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ON3D is the device name listed in this FDA 510(k) record. The listed applicant is 3D Ons, Inc.. It received FDA 510(k) clearance on 2022-05-23 under 510(k) number K221000. 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 ON3D?

ON3D is a medical device that received FDA 510(k) clearance on 2022-05-23. The listed applicant is 3D Ons, Inc.. The 510(k) number is K221000.

When did ON3D receive FDA 510(k) clearance?

ON3D received FDA 510(k) clearance on 2022-05-23, under 510(k) number K221000.

Who is the listed applicant for ON3D?

The FDA 510(k) record lists 3D Ons, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ON3D?

The FDA product code for ON3D is LLZ.

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