FDA 510(k)

EMA 3D

Número K: K232735 · 2024-05-03

Data da decisão2024-05-03

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

EMA 3D is the device name listed in this FDA 510(k) record. The listed applicant is Ema Sleep Incorporated. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K232735. 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 EMA 3D?

EMA 3D is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Ema Sleep Incorporated. The 510(k) number is K232735.

When did EMA 3D receive FDA 510(k) clearance?

EMA 3D received FDA 510(k) clearance on 2024-05-03, under 510(k) number K232735.

Who is the listed applicant for EMA 3D?

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

What is the FDA product code for EMA 3D?

The FDA product code for EMA 3D is LRK.

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Fonte oficial

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