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FDA 510(k)

Salem Sump Dual Lumen Stomach Tube with ENFit Connection

Número K: K190923 · 2019-11-07

RequerenteCardinalhealth
Data da decisão2019-11-07
Código do produtoPIF
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Salem Sump Dual Lumen Stomach Tube with ENFit Connection is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K190923. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Salem Sump Dual Lumen Stomach Tube with ENFit Connection?

Salem Sump Dual Lumen Stomach Tube with ENFit Connection is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Cardinalhealth. The 510(k) number is K190923.

When did Salem Sump Dual Lumen Stomach Tube with ENFit Connection receive FDA 510(k) clearance?

Salem Sump Dual Lumen Stomach Tube with ENFit Connection received FDA 510(k) clearance on 2019-11-07, under 510(k) number K190923.

Who is the listed applicant for Salem Sump Dual Lumen Stomach Tube with ENFit Connection?

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

What is the FDA product code for Salem Sump Dual Lumen Stomach Tube with ENFit Connection?

The FDA product code for Salem Sump Dual Lumen Stomach Tube with ENFit Connection is PIF.

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Fonte oficial

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