FDA 510(k)

DOC Band 3D

Número K: K244056 · 2025-03-17

Data da decisão2025-03-17

Código do produtoOAN

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DOC Band 3D is the device name listed in this FDA 510(k) record. The listed applicant is Cranial Technologies, Inc.. It received FDA 510(k) clearance on 2025-03-17 under 510(k) number K244056. The device is classified under product code OAN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DOC Band 3D?

DOC Band 3D is a medical device that received FDA 510(k) clearance on 2025-03-17. The listed applicant is Cranial Technologies, Inc.. The 510(k) number is K244056.

When did DOC Band 3D receive FDA 510(k) clearance?

DOC Band 3D received FDA 510(k) clearance on 2025-03-17, under 510(k) number K244056.

Who is the listed applicant for DOC Band 3D?

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

What is the FDA product code for DOC Band 3D?

The FDA product code for DOC Band 3D is OAN.

Dispositivos Relacionados (Código: OAN)

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