FDA 510(k)

CapKlenZ

Número K: K192382 · 2020-04-20

Data da decisão2020-04-20

Código do produtoQBP

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

CapKlenZ is the device name listed in this FDA 510(k) record. The listed applicant is Star Mountain Medical, Inc.. It received FDA 510(k) clearance on 2020-04-20 under 510(k) number K192382. The device is classified under product code QBP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CapKlenZ?

CapKlenZ is a medical device that received FDA 510(k) clearance on 2020-04-20. The listed applicant is Star Mountain Medical, Inc.. The 510(k) number is K192382.

When did CapKlenZ receive FDA 510(k) clearance?

CapKlenZ received FDA 510(k) clearance on 2020-04-20, under 510(k) number K192382.

Who is the listed applicant for CapKlenZ?

The FDA 510(k) record lists Star Mountain Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CapKlenZ?

The FDA product code for CapKlenZ is QBP.

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