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FDA 510(k)

Vivo 45 LS

N.º K: K232365 · 2025-12-19

SolicitanteOconnell Regulatory Consultants, Inc.
Fecha de decisión2025-12-19
Código de productoCBK
Comité asesorAN
DecisiónSubstantially Equivalent

Resumen del dispositivo

Vivo 45 LS is the device name listed in this FDA 510(k) record. The listed applicant is Oconnell Regulatory Consultants, Inc.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K232365. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vivo 45 LS?

Vivo 45 LS is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Oconnell Regulatory Consultants, Inc.. The 510(k) number is K232365.

When did Vivo 45 LS receive FDA 510(k) clearance?

Vivo 45 LS received FDA 510(k) clearance on 2025-12-19, under 510(k) number K232365.

Who is the listed applicant for Vivo 45 LS?

The FDA 510(k) record lists Oconnell Regulatory Consultants, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vivo 45 LS?

The FDA product code for Vivo 45 LS is CBK.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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