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FDA 510(k)

Aluna 2

K-Number: K232588 · 2024-11-25

ApplicantKnox Medical Diagnostics
Decision Date2024-11-25
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Aluna 2 is a medical device manufactured by Knox Medical Diagnostics. It received FDA 510(k) clearance on 2024-11-25 under approval number K232588. 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 2?

Aluna 2 is a medical device that received FDA 510(k) clearance on 2024-11-25. It is manufactured by Knox Medical Diagnostics. The 510(k) number is K232588.

When was Aluna 2 approved by the FDA?

Aluna 2 received FDA 510(k) clearance on 2024-11-25, under approval number K232588.

What company makes Aluna 2?

Aluna 2 is manufactured by Knox Medical Diagnostics.

What is the FDA product code for Aluna 2?

The FDA product code for Aluna 2 is BZH.

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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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