FDA 510(k)

Twilite Appliance

Número K: K190687 · 2019-07-02

Data da decisão2019-07-02

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Twilite Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Stephen J Harkins, Dds, PC. It received FDA 510(k) clearance on 2019-07-02 under 510(k) number K190687. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Twilite Appliance?

Twilite Appliance is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Stephen J Harkins, Dds, PC. The 510(k) number is K190687.

When did Twilite Appliance receive FDA 510(k) clearance?

Twilite Appliance received FDA 510(k) clearance on 2019-07-02, under 510(k) number K190687.

Who is the listed applicant for Twilite Appliance?

The FDA 510(k) record lists Stephen J Harkins, Dds, PC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Twilite Appliance?

The FDA product code for Twilite Appliance is LRK.

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