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FDA 510(k)

Aurora

K-Number: K181636 · 2018-07-20

ApplicantSodium Systems, LLC
Decision Date2018-07-20
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Aurora is a medical device manufactured by Sodium Systems, LLC. It received FDA 510(k) clearance on 2018-07-20 under approval number K181636. The device is classified under product code MUH. It was reviewed by the DE 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 2018-07-20. It is manufactured by Sodium Systems, LLC. The 510(k) number is K181636.

When was Aurora approved by the FDA?

Aurora received FDA 510(k) clearance on 2018-07-20, under approval number K181636.

What company makes Aurora?

Aurora is manufactured by Sodium Systems, LLC.

What is the FDA product code for Aurora?

The FDA product code for Aurora is MUH.

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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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