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PMA de la FDA

Implant, hearing, active, middle ear, partially implanted

Número de PMA: P010023 · 2020-10-28

SolicitanteOtotronix, LLC
Fecha de decisión2020-10-28
Número PMAP010023
Código de productoMPV
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorEN

Resumen del dispositivo

Implant, hearing, active, middle ear, partially implanted is the device name listed in this FDA 510(k) record. The listed applicant is Ototronix, LLC. It received FDA 510(k) clearance on 2020-10-28. The device is classified under product code MPV. It was reviewed by the EN advisory panel.

Preguntas frecuentes

What is the Implant, hearing, active, middle ear, partially implanted?

Implant, hearing, active, middle ear, partially implanted is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Ototronix, LLC.

When did Implant, hearing, active, middle ear, partially implanted receive FDA 510(k) clearance?

The clearance date for Implant, hearing, active, middle ear, partially implanted can be found in the official FDA records.

Who is the listed applicant for Implant, hearing, active, middle ear, partially implanted?

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

What is the FDA product code for Implant, hearing, active, middle ear, partially implanted?

The FDA product code for Implant, hearing, active, middle ear, partially implanted is MPV.

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Fuente oficial

Ver en la base de datos de la FDA →

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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