FDA 510(k)

Endotracheal Tube with Evacuation Lumen

Número K: K182739 · 2019-12-11

Data da decisão2019-12-11

Código do produtoBTR

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Endotracheal Tube with Evacuation Lumen is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-12-11 under 510(k) number K182739. 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 Endotracheal Tube with Evacuation Lumen?

Endotracheal Tube with Evacuation Lumen is a medical device that received FDA 510(k) clearance on 2019-12-11. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K182739.

When did Endotracheal Tube with Evacuation Lumen receive FDA 510(k) clearance?

Endotracheal Tube with Evacuation Lumen received FDA 510(k) clearance on 2019-12-11, under 510(k) number K182739.

Who is the listed applicant for Endotracheal Tube with Evacuation Lumen?

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

What is the FDA product code for Endotracheal Tube with Evacuation Lumen?

The FDA product code for Endotracheal Tube with Evacuation Lumen is BTR.

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Fonte oficial

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