FDA 510(k)

Triathlon Pro

N.º K: K243131 · 2025-11-07

Fecha de decisión2025-11-07

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Triathlon Pro is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Biomedical. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K243131. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Triathlon Pro?

Triathlon Pro is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Sigma Biomedical. The 510(k) number is K243131.

When did Triathlon Pro receive FDA 510(k) clearance?

Triathlon Pro received FDA 510(k) clearance on 2025-11-07, under 510(k) number K243131.

Who is the listed applicant for Triathlon Pro?

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

What is the FDA product code for Triathlon Pro?

The FDA product code for Triathlon Pro is NUH.

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