FDA 510(k)

AT

Número K: K212645 · 2021-12-16

Data da decisão2021-12-16

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

AT is the device name listed in this FDA 510(k) record. The listed applicant is At Glove Engineering Sdn. Bhd. It received FDA 510(k) clearance on 2021-12-16 under 510(k) number K212645. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AT?

AT is a medical device that received FDA 510(k) clearance on 2021-12-16. The listed applicant is At Glove Engineering Sdn. Bhd. The 510(k) number is K212645.

When did AT receive FDA 510(k) clearance?

AT received FDA 510(k) clearance on 2021-12-16, under 510(k) number K212645.

Who is the listed applicant for AT?

The FDA 510(k) record lists At Glove Engineering Sdn. Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AT?

The FDA product code for AT is LZA.

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