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FDA 510(k)

Aurora

K-Number: K231355 · 2024-02-09

ApplicantEnsodata
Decision Date2024-02-09
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Aurora is a medical device manufactured by Ensodata. It received FDA 510(k) clearance on 2024-02-09 under approval number K231355. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aurora?

Aurora is a medical device that received FDA 510(k) clearance on 2024-02-09. It is manufactured by Ensodata. The 510(k) number is K231355.

When was Aurora approved by the FDA?

Aurora received FDA 510(k) clearance on 2024-02-09, under approval number K231355.

What company makes Aurora?

Aurora is manufactured by Ensodata.

What is the FDA product code for Aurora?

The FDA product code for Aurora is MNR.

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Official Source

View on FDA Database →

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

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