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FDA 510(k)

Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection

Número K: K213174 · 2022-05-19

RequerenteCardinalhealth
Data da decisão2022-05-19
Código do produtoPIF
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Salem Sump Silicone 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 2022-05-19 under 510(k) number K213174. 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 Silicone Dual Lumen Stomach Tube with ENFit Connection?

Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Cardinalhealth. The 510(k) number is K213174.

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

Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection received FDA 510(k) clearance on 2022-05-19, under 510(k) number K213174.

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

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

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Fonte oficial

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