FDA 510(k)

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL

Número K: K201936 · 2021-05-06

Data da decisão2021-05-06

Código do produtoKPE

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL is the device name listed in this FDA 510(k) record. The listed applicant is Gilero, LLC. It received FDA 510(k) clearance on 2021-05-06 under 510(k) number K201936. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL?

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL is a medical device that received FDA 510(k) clearance on 2021-05-06. The listed applicant is Gilero, LLC. The 510(k) number is K201936.

When did SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL receive FDA 510(k) clearance?

SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL received FDA 510(k) clearance on 2021-05-06, under 510(k) number K201936.

Who is the listed applicant for SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL?

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

What is the FDA product code for SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL?

The FDA product code for SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL is KPE.

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