FDA 510(k)

NanoPress 760A-BT (760A-BT)

Número K: K254267 · 2026-02-24

Data da decisão2026-02-24

Código do produtoJOW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

NanoPress 760A-BT (760A-BT) is the device name listed in this FDA 510(k) record. The listed applicant is Mego Afek , Ltd.. It received FDA 510(k) clearance on 2026-02-24 under 510(k) number K254267. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NanoPress 760A-BT (760A-BT)?

NanoPress 760A-BT (760A-BT) is a medical device that received FDA 510(k) clearance on 2026-02-24. The listed applicant is Mego Afek , Ltd.. The 510(k) number is K254267.

When did NanoPress 760A-BT (760A-BT) receive FDA 510(k) clearance?

NanoPress 760A-BT (760A-BT) received FDA 510(k) clearance on 2026-02-24, under 510(k) number K254267.

Who is the listed applicant for NanoPress 760A-BT (760A-BT)?

The FDA 510(k) record lists Mego Afek , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NanoPress 760A-BT (760A-BT)?

The FDA product code for NanoPress 760A-BT (760A-BT) is JOW.

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