FDA 510(k)

Smart Kit Basic, Smart Kit Pro

Número K: K202443 · 2021-03-11

Data da decisão2021-03-11

Código do produtoMUU

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Smart Kit Basic, Smart Kit Pro is the device name listed in this FDA 510(k) record. The listed applicant is Bsl Co., Ltd.. It received FDA 510(k) clearance on 2021-03-11 under 510(k) number K202443. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Smart Kit Basic, Smart Kit Pro?

Smart Kit Basic, Smart Kit Pro is a medical device that received FDA 510(k) clearance on 2021-03-11. The listed applicant is Bsl Co., Ltd.. The 510(k) number is K202443.

When did Smart Kit Basic, Smart Kit Pro receive FDA 510(k) clearance?

Smart Kit Basic, Smart Kit Pro received FDA 510(k) clearance on 2021-03-11, under 510(k) number K202443.

Who is the listed applicant for Smart Kit Basic, Smart Kit Pro?

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

What is the FDA product code for Smart Kit Basic, Smart Kit Pro?

The FDA product code for Smart Kit Basic, Smart Kit Pro is MUU.

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