FDA 510(k)

S-Line

Número K: K213191 · 2022-05-24

Data da decisão2022-05-24

Código do produtoLGZ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

S-Line is the device name listed in this FDA 510(k) record. The listed applicant is Barkey GmbH & Co. KG. It received FDA 510(k) clearance on 2022-05-24 under 510(k) number K213191. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the S-Line?

S-Line is a medical device that received FDA 510(k) clearance on 2022-05-24. The listed applicant is Barkey GmbH & Co. KG. The 510(k) number is K213191.

When did S-Line receive FDA 510(k) clearance?

S-Line received FDA 510(k) clearance on 2022-05-24, under 510(k) number K213191.

Who is the listed applicant for S-Line?

The FDA 510(k) record lists Barkey GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-Line?

The FDA product code for S-Line is LGZ.

Dispositivos Relacionados (Código: LGZ)

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Fonte oficial

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