FDA 510(k)

The iMask Child's Face Mask

Número K: K202831 · 2021-08-26

Data da decisão2021-08-26

Código do produtoOXZ

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

The iMask Child's Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent, Inc.. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K202831. The device is classified under product code OXZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the The iMask Child's Face Mask?

The iMask Child's Face Mask is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Pac-Dent, Inc.. The 510(k) number is K202831.

When did The iMask Child's Face Mask receive FDA 510(k) clearance?

The iMask Child's Face Mask received FDA 510(k) clearance on 2021-08-26, under 510(k) number K202831.

Who is the listed applicant for The iMask Child's Face Mask?

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

What is the FDA product code for The iMask Child's Face Mask?

The FDA product code for The iMask Child's Face Mask is OXZ.

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Outros registros que listam Pac-Dent, Inc. como candidato(a)

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Dispositivos Relacionados (Código: OXZ)

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Fonte oficial

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