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FDA 510(k)

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL

Número K: K200583 · 2023-09-05

RequerenteKi Mobility, LLC
Data da decisão2023-09-05
Código do produtoIOR
Comité consultivoPM
DecisãoSubstantially Equivalent

Resumo do dispositivo

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL is the device name listed in this FDA 510(k) record. The listed applicant is Ki Mobility, LLC. It received FDA 510(k) clearance on 2023-09-05 under 510(k) number K200583. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL?

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL is a medical device that received FDA 510(k) clearance on 2023-09-05. The listed applicant is Ki Mobility, LLC. The 510(k) number is K200583.

When did Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL receive FDA 510(k) clearance?

Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL received FDA 510(k) clearance on 2023-09-05, under 510(k) number K200583.

Who is the listed applicant for Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL?

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

What is the FDA product code for Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL?

The FDA product code for Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL is IOR.

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Fonte oficial

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