FDA 510(k)

KnoxFog Anti-fogging Device

Número K: K251068 · 2025-08-27

Data da decisão2025-08-27

Código do produtoOCT

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

KnoxFog Anti-fogging Device is the device name listed in this FDA 510(k) record. The listed applicant is Uv One Hygienics, Inc.. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K251068. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the KnoxFog Anti-fogging Device?

KnoxFog Anti-fogging Device is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Uv One Hygienics, Inc.. The 510(k) number is K251068.

When did KnoxFog Anti-fogging Device receive FDA 510(k) clearance?

KnoxFog Anti-fogging Device received FDA 510(k) clearance on 2025-08-27, under 510(k) number K251068.

Who is the listed applicant for KnoxFog Anti-fogging Device?

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

What is the FDA product code for KnoxFog Anti-fogging Device?

The FDA product code for KnoxFog Anti-fogging Device is OCT.

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Fonte oficial

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