FDA 510(k)

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG

N.º K: K233922 · 2024-03-11

Fecha de decisión2024-03-11

Código de productoELC

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG is the device name listed in this FDA 510(k) record. The listed applicant is Satelec - Acteon Group. It received FDA 510(k) clearance on 2024-03-11 under 510(k) number K233922. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG?

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG is a medical device that received FDA 510(k) clearance on 2024-03-11. The listed applicant is Satelec - Acteon Group. The 510(k) number is K233922.

When did SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG receive FDA 510(k) clearance?

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG received FDA 510(k) clearance on 2024-03-11, under 510(k) number K233922.

Who is the listed applicant for SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG?

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

What is the FDA product code for SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG?

The FDA product code for SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG is ELC.

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Otros registros que enlistan a Satelec - Acteon Group como solicitante

K172137PIEZOTOME CUBE

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Fuente oficial

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