FDA 510(k)

CoreLite X-Ray Specimen Cabinet

Número K: K193317 · 2019-12-13

Data da decisão2019-12-13

Código do produtoMWP

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

CoreLite X-Ray Specimen Cabinet is the device name listed in this FDA 510(k) record. The listed applicant is Cirdan Imaging Limited. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K193317. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CoreLite X-Ray Specimen Cabinet?

CoreLite X-Ray Specimen Cabinet is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Cirdan Imaging Limited. The 510(k) number is K193317.

When did CoreLite X-Ray Specimen Cabinet receive FDA 510(k) clearance?

CoreLite X-Ray Specimen Cabinet received FDA 510(k) clearance on 2019-12-13, under 510(k) number K193317.

Who is the listed applicant for CoreLite X-Ray Specimen Cabinet?

The FDA 510(k) record lists Cirdan Imaging Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoreLite X-Ray Specimen Cabinet?

The FDA product code for CoreLite X-Ray Specimen Cabinet is MWP.

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