FDA 510(k)

T-SHAPE 2

Número K: K231092 · 2023-09-22

RequerenteB&M S.R.L. Marketing Nel Benessere

Data da decisão2023-09-22

Código do produtoNUV

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

T-SHAPE 2 is the device name listed in this FDA 510(k) record. The listed applicant is B&M S.R.L. Marketing Nel Benessere. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K231092. The device is classified under product code NUV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the T-SHAPE 2?

T-SHAPE 2 is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is B&M S.R.L. Marketing Nel Benessere. The 510(k) number is K231092.

When did T-SHAPE 2 receive FDA 510(k) clearance?

T-SHAPE 2 received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231092.

Who is the listed applicant for T-SHAPE 2?

The FDA 510(k) record lists B&M S.R.L. Marketing Nel Benessere as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T-SHAPE 2?

The FDA product code for T-SHAPE 2 is NUV.

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