FDA 510(k)

Medipoint Blood Lancets

Número K: K223480 · 2023-01-13

Data da decisão2023-01-13

Código do produtoQRK

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medipoint Blood Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Medipoint Holdings, LLC. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K223480. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medipoint Blood Lancets?

Medipoint Blood Lancets is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Medipoint Holdings, LLC. The 510(k) number is K223480.

When did Medipoint Blood Lancets receive FDA 510(k) clearance?

Medipoint Blood Lancets received FDA 510(k) clearance on 2023-01-13, under 510(k) number K223480.

Who is the listed applicant for Medipoint Blood Lancets?

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

What is the FDA product code for Medipoint Blood Lancets?

The FDA product code for Medipoint Blood Lancets is QRK.

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Dispositivos Relacionados (Código: QRK)

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Fonte oficial

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