FDA 510(k)

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector

Número K: K200388 · 2020-04-14

Data da decisão2020-04-14

Código do produtoOCX

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2020-04-14 under 510(k) number K200388. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is a medical device that received FDA 510(k) clearance on 2020-04-14. The listed applicant is Ga Health Company Limited. The 510(k) number is K200388.

When did Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector receive FDA 510(k) clearance?

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector received FDA 510(k) clearance on 2020-04-14, under 510(k) number K200388.

Who is the listed applicant for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

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

What is the FDA product code for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector?

The FDA product code for Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector is OCX.

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Fonte oficial

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