FDA 510(k)

Glide (91000-GL-X)

Número K: K240884 · 2024-04-15

RequerenteInfinite Biomedical Technologies, LLC

Data da decisão2024-04-15

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Glide (91000-GL-X) is the device name listed in this FDA 510(k) record. The listed applicant is Infinite Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2024-04-15 under 510(k) number K240884. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Glide (91000-GL-X)?

Glide (91000-GL-X) is a medical device that received FDA 510(k) clearance on 2024-04-15. The listed applicant is Infinite Biomedical Technologies, LLC. The 510(k) number is K240884.

When did Glide (91000-GL-X) receive FDA 510(k) clearance?

Glide (91000-GL-X) received FDA 510(k) clearance on 2024-04-15, under 510(k) number K240884.

Who is the listed applicant for Glide (91000-GL-X)?

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

What is the FDA product code for Glide (91000-GL-X)?

The FDA product code for Glide (91000-GL-X) is GXY.

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Fonte oficial

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