FDA 510(k)

armor LC

Número K: K182118 · 2019-05-03

Data da decisão2019-05-03

Código do produtoEIE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

armor LC is the device name listed in this FDA 510(k) record. The listed applicant is Mavrik Dental Systems, Ltd.. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K182118. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the armor LC?

armor LC is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Mavrik Dental Systems, Ltd.. The 510(k) number is K182118.

When did armor LC receive FDA 510(k) clearance?

armor LC received FDA 510(k) clearance on 2019-05-03, under 510(k) number K182118.

Who is the listed applicant for armor LC?

The FDA 510(k) record lists Mavrik Dental Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for armor LC?

The FDA product code for armor LC is EIE.

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Fonte oficial

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