FDA 510(k)

V-HEPES PLUS

Número K: K213293 · 2022-09-14

Data da decisão2022-09-14

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

V-HEPES PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Vitromed Langenfeld. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K213293. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the V-HEPES PLUS?

V-HEPES PLUS is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Vitromed Langenfeld. The 510(k) number is K213293.

When did V-HEPES PLUS receive FDA 510(k) clearance?

V-HEPES PLUS received FDA 510(k) clearance on 2022-09-14, under 510(k) number K213293.

Who is the listed applicant for V-HEPES PLUS?

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

What is the FDA product code for V-HEPES PLUS?

The FDA product code for V-HEPES PLUS is MQL.

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