FDA 510(k)

Express 4 Sleep appliance/CPAP Sidekick appliance

Número K: K173856 · 2018-06-26

Data da decisão2018-06-26

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Express 4 Sleep appliance/CPAP Sidekick appliance is the device name listed in this FDA 510(k) record. The listed applicant is Moses Appliances, LLC. It received FDA 510(k) clearance on 2018-06-26 under 510(k) number K173856. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Express 4 Sleep appliance/CPAP Sidekick appliance?

Express 4 Sleep appliance/CPAP Sidekick appliance is a medical device that received FDA 510(k) clearance on 2018-06-26. The listed applicant is Moses Appliances, LLC. The 510(k) number is K173856.

When did Express 4 Sleep appliance/CPAP Sidekick appliance receive FDA 510(k) clearance?

Express 4 Sleep appliance/CPAP Sidekick appliance received FDA 510(k) clearance on 2018-06-26, under 510(k) number K173856.

Who is the listed applicant for Express 4 Sleep appliance/CPAP Sidekick appliance?

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

What is the FDA product code for Express 4 Sleep appliance/CPAP Sidekick appliance?

The FDA product code for Express 4 Sleep appliance/CPAP Sidekick appliance is LRK.

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