FDA 510(k)

U&U Blood Collection Sets

Número K: K181508 · 2019-02-13

RequerenteU&U Medical Technology Co, Ltd.

Data da decisão2019-02-13

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

U&U Blood Collection Sets is the device name listed in this FDA 510(k) record. The listed applicant is U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2019-02-13 under 510(k) number K181508. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the U&U Blood Collection Sets?

U&U Blood Collection Sets is a medical device that received FDA 510(k) clearance on 2019-02-13. The listed applicant is U&U Medical Technology Co, Ltd.. The 510(k) number is K181508.

When did U&U Blood Collection Sets receive FDA 510(k) clearance?

U&U Blood Collection Sets received FDA 510(k) clearance on 2019-02-13, under 510(k) number K181508.

Who is the listed applicant for U&U Blood Collection Sets?

The FDA 510(k) record lists U&U Medical Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U&U Blood Collection Sets?

The FDA product code for U&U Blood Collection Sets is FMI.

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