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FDA 510(k)

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X

N.º K: K220698 · 2023-02-16

SolicitantePanthera AB
Fecha de decisión2023-02-16
Código de productoIOR
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X is the device name listed in this FDA 510(k) record. The listed applicant is Panthera AB. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K220698. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Bambino 3, S3 and S3 Swing, U3 and U3 Light, X?

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Panthera AB. The 510(k) number is K220698.

When did Bambino 3, S3 and S3 Swing, U3 and U3 Light, X receive FDA 510(k) clearance?

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X received FDA 510(k) clearance on 2023-02-16, under 510(k) number K220698.

Who is the listed applicant for Bambino 3, S3 and S3 Swing, U3 and U3 Light, X?

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

What is the FDA product code for Bambino 3, S3 and S3 Swing, U3 and U3 Light, X?

The FDA product code for Bambino 3, S3 and S3 Swing, U3 and U3 Light, X is IOR.

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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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