FDA 510(k)

DreamClear

Número K: K240646 · 2024-09-04

RequerenteSomnomed Technologies Inc., Doing Business AS Remware

Data da decisão2024-09-04

Código do produtoGWL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DreamClear is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed Technologies Inc., Doing Business AS Remware. It received FDA 510(k) clearance on 2024-09-04 under 510(k) number K240646. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DreamClear?

DreamClear is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is Somnomed Technologies Inc., Doing Business AS Remware. The 510(k) number is K240646.

When did DreamClear receive FDA 510(k) clearance?

DreamClear received FDA 510(k) clearance on 2024-09-04, under 510(k) number K240646.

Who is the listed applicant for DreamClear?

The FDA 510(k) record lists Somnomed Technologies Inc., Doing Business AS Remware as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DreamClear?

The FDA product code for DreamClear is GWL.

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