FDA 510(k)

Sheridan Spiral-Flex Endotracheal Tubes

Número K: K192324 · 2019-12-06

Data da decisão2019-12-06

Código do produtoBTR

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sheridan Spiral-Flex Endotracheal Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K192324. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sheridan Spiral-Flex Endotracheal Tubes?

Sheridan Spiral-Flex Endotracheal Tubes is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K192324.

When did Sheridan Spiral-Flex Endotracheal Tubes receive FDA 510(k) clearance?

Sheridan Spiral-Flex Endotracheal Tubes received FDA 510(k) clearance on 2019-12-06, under 510(k) number K192324.

Who is the listed applicant for Sheridan Spiral-Flex Endotracheal Tubes?

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

What is the FDA product code for Sheridan Spiral-Flex Endotracheal Tubes?

The FDA product code for Sheridan Spiral-Flex Endotracheal Tubes is BTR.

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Fonte oficial

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