FDA 510(k)

MySleepDash

Número K: K252338 · 2026-04-17

RequerenteSomnetics International, Inc. (Dba Transcend Inc)

Data da decisão2026-04-17

Código do produtoBZD

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

MySleepDash is the device name listed in this FDA 510(k) record. The listed applicant is Somnetics International, Inc. (Dba Transcend Inc). It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K252338. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MySleepDash?

MySleepDash is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Somnetics International, Inc. (Dba Transcend Inc). The 510(k) number is K252338.

When did MySleepDash receive FDA 510(k) clearance?

MySleepDash received FDA 510(k) clearance on 2026-04-17, under 510(k) number K252338.

Who is the listed applicant for MySleepDash?

The FDA 510(k) record lists Somnetics International, Inc. (Dba Transcend Inc) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MySleepDash?

The FDA product code for MySleepDash is BZD.

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Fonte oficial

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