FDA 510(k)

NuEra Tight RF Family

Número K: K223856 · 2023-08-11

Data da decisão2023-08-11

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

NuEra Tight RF Family is the device name listed in this FDA 510(k) record. The listed applicant is Bios S.R.L.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K223856. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NuEra Tight RF Family?

NuEra Tight RF Family is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Bios S.R.L.. The 510(k) number is K223856.

When did NuEra Tight RF Family receive FDA 510(k) clearance?

NuEra Tight RF Family received FDA 510(k) clearance on 2023-08-11, under 510(k) number K223856.

Who is the listed applicant for NuEra Tight RF Family?

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

What is the FDA product code for NuEra Tight RF Family?

The FDA product code for NuEra Tight RF Family is GEI.

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Outros registros que listam Bios S.R.L. como candidato(a)

K243445Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)K230755NuEra Tight RF Model OptiStream K223907NuEra Tight RF Model APMD145.M70-US K210867NuEra Tight RF, NuEra Tight RF Plus K201239NuEra Tight Family, EMS Model

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Fonte oficial

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