FDA 510(k)

Intellidrop

Número K: K251598 · 2025-12-10

Data da decisão2025-12-10

Código do produtoJXG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Intellidrop is the device name listed in this FDA 510(k) record. The listed applicant is Brainspace, Inc.. It received FDA 510(k) clearance on 2025-12-10 under 510(k) number K251598. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Intellidrop?

Intellidrop is a medical device that received FDA 510(k) clearance on 2025-12-10. The listed applicant is Brainspace, Inc.. The 510(k) number is K251598.

When did Intellidrop receive FDA 510(k) clearance?

Intellidrop received FDA 510(k) clearance on 2025-12-10, under 510(k) number K251598.

Who is the listed applicant for Intellidrop?

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

What is the FDA product code for Intellidrop?

The FDA product code for Intellidrop is JXG.

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