FDA 510(k)

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus

Número K: K243533 · 2025-01-13

Data da decisão2025-01-13

Código do produtoFMK

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is the device name listed in this FDA 510(k) record. The listed applicant is Hlb Co., Ltd. Healthcare. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K243533. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Hlb Co., Ltd. Healthcare. The 510(k) number is K243533.

When did Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus receive FDA 510(k) clearance?

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus received FDA 510(k) clearance on 2025-01-13, under 510(k) number K243533.

Who is the listed applicant for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

The FDA 510(k) record lists Hlb Co., Ltd. Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

The FDA product code for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is FMK.

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Fonte oficial

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