FDA 510(k)

EchoGlo Needle

Número K: K171968 · 2018-01-25

Data da decisão2018-01-25

Código do produtoBSP

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

EchoGlo Needle is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-01-25 under 510(k) number K171968. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EchoGlo Needle?

EchoGlo Needle is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K171968.

When did EchoGlo Needle receive FDA 510(k) clearance?

EchoGlo Needle received FDA 510(k) clearance on 2018-01-25, under 510(k) number K171968.

Who is the listed applicant for EchoGlo Needle?

The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EchoGlo Needle?

The FDA product code for EchoGlo Needle is BSP.

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Fonte oficial

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