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PMA de la FDA

Prosthesis, breast, inflatable, internal, saline

Número de PMA: P120011 · 2025-02-11

SolicitanteBimini Health Tech
Fecha de decisión2025-02-11
Número PMAP120011
Código de productoFWM
Clase del dispositivoClase 3
Especialidad médicaG
Número de regulación21 CFR 8
Comité asesorSU

Resumen del dispositivo

Prosthesis, breast, inflatable, internal, saline is the device name listed in this FDA 510(k) record. The listed applicant is Bimini Health Tech. It received FDA 510(k) clearance on 2025-02-11. The device is classified under product code FWM. It was reviewed by the SU advisory panel.

Preguntas frecuentes

What is the Prosthesis, breast, inflatable, internal, saline?

Prosthesis, breast, inflatable, internal, saline is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Bimini Health Tech.

When did Prosthesis, breast, inflatable, internal, saline receive FDA 510(k) clearance?

The clearance date for Prosthesis, breast, inflatable, internal, saline can be found in the official FDA records.

Who is the listed applicant for Prosthesis, breast, inflatable, internal, saline?

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

What is the FDA product code for Prosthesis, breast, inflatable, internal, saline?

The FDA product code for Prosthesis, breast, inflatable, internal, saline is FWM.

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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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