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FDA 510(k)

Aluna

K-Number: K193311 · 2020-03-25

ApplicantKnox Medical Diagnostics, Inc.
Decision Date2020-03-25
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Aluna is a medical device manufactured by Knox Medical Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-03-25 under approval number K193311. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aluna?

Aluna is a medical device that received FDA 510(k) clearance on 2020-03-25. It is manufactured by Knox Medical Diagnostics, Inc.. The 510(k) number is K193311.

When was Aluna approved by the FDA?

Aluna received FDA 510(k) clearance on 2020-03-25, under approval number K193311.

What company makes Aluna?

Aluna is manufactured by Knox Medical Diagnostics, Inc..

What is the FDA product code for Aluna?

The FDA product code for Aluna is BZH.

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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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