FDA 510(k)

Nano FortiCore, FortiCore

Número K: K191822 · 2019-10-11

Data da decisão2019-10-11

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nano FortiCore, FortiCore is the device name listed in this FDA 510(k) record. The listed applicant is Nanovis, LLC. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K191822. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Nano FortiCore, FortiCore?

Nano FortiCore, FortiCore is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Nanovis, LLC. The 510(k) number is K191822.

When did Nano FortiCore, FortiCore receive FDA 510(k) clearance?

Nano FortiCore, FortiCore received FDA 510(k) clearance on 2019-10-11, under 510(k) number K191822.

Who is the listed applicant for Nano FortiCore, FortiCore?

The FDA 510(k) record lists Nanovis, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nano FortiCore, FortiCore?

The FDA product code for Nano FortiCore, FortiCore is ODP.

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