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FDA 510(k)

e-Celsius Medical System

N.º K: K210924 · 2023-06-28

SolicitanteBodycap
Fecha de decisión2023-06-28
Código de productoFLL
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

e-Celsius Medical System is the device name listed in this FDA 510(k) record. The listed applicant is Bodycap. It received FDA 510(k) clearance on 2023-06-28 under 510(k) number K210924. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the e-Celsius Medical System?

e-Celsius Medical System is a medical device that received FDA 510(k) clearance on 2023-06-28. The listed applicant is Bodycap. The 510(k) number is K210924.

When did e-Celsius Medical System receive FDA 510(k) clearance?

e-Celsius Medical System received FDA 510(k) clearance on 2023-06-28, under 510(k) number K210924.

Who is the listed applicant for e-Celsius Medical System?

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

What is the FDA product code for e-Celsius Medical System?

The FDA product code for e-Celsius Medical System is FLL.

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Dispositivos relacionados (Código: FLL)

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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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