FDA 510(k)

AsoAligner

Número K: K201104 · 2021-02-26

RequerenteAso International Manila, Inc.

Data da decisão2021-02-26

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

AsoAligner is the device name listed in this FDA 510(k) record. The listed applicant is Aso International Manila, Inc.. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K201104. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AsoAligner?

AsoAligner is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Aso International Manila, Inc.. The 510(k) number is K201104.

When did AsoAligner receive FDA 510(k) clearance?

AsoAligner received FDA 510(k) clearance on 2021-02-26, under 510(k) number K201104.

Who is the listed applicant for AsoAligner?

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

What is the FDA product code for AsoAligner?

The FDA product code for AsoAligner is NXC.

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Fonte oficial

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