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FDA 510(k)

Sonu

Número K: K242214 · 2025-04-24

RequerenteSound Health Systems, Inc.
Data da decisão2025-04-24
Código do produtoQZC
Comité consultivoEN
DecisãoSubstantially Equivalent

Resumo do dispositivo

Sonu is the device name listed in this FDA 510(k) record. The listed applicant is Sound Health Systems, Inc.. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K242214. The device is classified under product code QZC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sonu?

Sonu is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Sound Health Systems, Inc.. The 510(k) number is K242214.

When did Sonu receive FDA 510(k) clearance?

Sonu received FDA 510(k) clearance on 2025-04-24, under 510(k) number K242214.

Who is the listed applicant for Sonu?

The FDA 510(k) record lists Sound Health Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sonu?

The FDA product code for Sonu is QZC.

Fonte oficial

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