FDA 510(k)

MySleepDash

N.º K: K252338 · 2026-04-17

SolicitanteSomnetics International, Inc. (Dba Transcend Inc)

Fecha de decisión2026-04-17

Código de productoBZD

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

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