FDA 510(k)

V-PRO maX 2 Low Temperature Sterilization System

Número K: K233065 · 2023-10-20

RequerenteSteris

Data da decisão2023-10-20

Código do produtoMLR

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

V-PRO maX 2 Low Temperature Sterilization System is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K233065. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the V-PRO maX 2 Low Temperature Sterilization System?

V-PRO maX 2 Low Temperature Sterilization System is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Steris. The 510(k) number is K233065.

When did V-PRO maX 2 Low Temperature Sterilization System receive FDA 510(k) clearance?

V-PRO maX 2 Low Temperature Sterilization System received FDA 510(k) clearance on 2023-10-20, under 510(k) number K233065.

Who is the listed applicant for V-PRO maX 2 Low Temperature Sterilization System?

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

What is the FDA product code for V-PRO maX 2 Low Temperature Sterilization System?

The FDA product code for V-PRO maX 2 Low Temperature Sterilization System is MLR.

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Fonte oficial

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