FDA 510(k)

si-Mochi

Número K: K202639 · 2021-04-21

Data da decisão2021-04-21

Código do produtoMQV

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

si-Mochi is the device name listed in this FDA 510(k) record. The listed applicant is Biostone, Ltd.. It received FDA 510(k) clearance on 2021-04-21 under 510(k) number K202639. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the si-Mochi?

si-Mochi is a medical device that received FDA 510(k) clearance on 2021-04-21. The listed applicant is Biostone, Ltd.. The 510(k) number is K202639.

When did si-Mochi receive FDA 510(k) clearance?

si-Mochi received FDA 510(k) clearance on 2021-04-21, under 510(k) number K202639.

Who is the listed applicant for si-Mochi?

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

What is the FDA product code for si-Mochi?

The FDA product code for si-Mochi is MQV.

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Fonte oficial

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