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FDA 510(k)

Ambra ProViewer

K-Number: K202335 · 2020-09-04

ApplicantDicom Grid Inc Dba Ambra Health
Decision Date2020-09-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Ambra ProViewer?

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

When was Ambra ProViewer approved by the FDA?

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

What company makes Ambra ProViewer?

Ambra ProViewer is manufactured by Dicom Grid Inc Dba Ambra Health.

What is the FDA product code for Ambra ProViewer?

The FDA product code for Ambra ProViewer is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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