FDA 510(k)

Ambra ProViewer

Número K: K202335 · 2020-09-04

RequerenteDicom Grid Inc Dba Ambra Health

Data da decisão2020-09-04

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ambra ProViewer is the device name listed in this FDA 510(k) record. The listed applicant is Dicom Grid Inc Dba Ambra Health. It received FDA 510(k) clearance on 2020-09-04 under 510(k) number K202335. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ambra ProViewer?

Ambra ProViewer is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Dicom Grid Inc Dba Ambra Health. The 510(k) number is K202335.

When did Ambra ProViewer receive FDA 510(k) clearance?

Ambra ProViewer received FDA 510(k) clearance on 2020-09-04, under 510(k) number K202335.

Who is the listed applicant for Ambra ProViewer?

The FDA 510(k) record lists Dicom Grid Inc Dba Ambra Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ambra ProViewer?

The FDA product code for Ambra ProViewer is LLZ.

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Fonte oficial

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