FDA 510(k)

T65 (9016E061-)

N.º K: K252032 · 2025-07-30

Fecha de decisión2025-07-30

Código de productoOBP

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

T65 (9016E061-) is the device name listed in this FDA 510(k) record. The listed applicant is Tonica Elektronik A/S. It received FDA 510(k) clearance on 2025-07-30 under 510(k) number K252032. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the T65 (9016E061-)?

T65 (9016E061-) is a medical device that received FDA 510(k) clearance on 2025-07-30. The listed applicant is Tonica Elektronik A/S. The 510(k) number is K252032.

When did T65 (9016E061-) receive FDA 510(k) clearance?

T65 (9016E061-) received FDA 510(k) clearance on 2025-07-30, under 510(k) number K252032.

Who is the listed applicant for T65 (9016E061-)?

The FDA 510(k) record lists Tonica Elektronik A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T65 (9016E061-)?

The FDA product code for T65 (9016E061-) is OBP.

Otros registros que enlistan a Tonica Elektronik A/S como solicitante

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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.