FDA 510(k)

HEBE (NP0000763)

N.º K: K241733 · 2025-04-16

Fecha de decisión2025-04-16

Código de productoPBX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

HEBE (NP0000763) is the device name listed in this FDA 510(k) record. The listed applicant is Novasonix Technology S.L.. It received FDA 510(k) clearance on 2025-04-16 under 510(k) number K241733. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HEBE (NP0000763)?

HEBE (NP0000763) is a medical device that received FDA 510(k) clearance on 2025-04-16. The listed applicant is Novasonix Technology S.L.. The 510(k) number is K241733.

When did HEBE (NP0000763) receive FDA 510(k) clearance?

HEBE (NP0000763) received FDA 510(k) clearance on 2025-04-16, under 510(k) number K241733.

Who is the listed applicant for HEBE (NP0000763)?

The FDA 510(k) record lists Novasonix Technology S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEBE (NP0000763)?

The FDA product code for HEBE (NP0000763) is PBX.

Dispositivos relacionados (Código: PBX)

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Fuente oficial

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