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FDA 510(k)

Akunah REFLECT

K-Number: K222987 · 2023-05-10

ApplicantAkunah Pty, Ltd.
Decision Date2023-05-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Akunah REFLECT is a medical device manufactured by Akunah Pty, Ltd.. It received FDA 510(k) clearance on 2023-05-10 under approval number K222987. 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 Akunah REFLECT?

Akunah REFLECT is a medical device that received FDA 510(k) clearance on 2023-05-10. It is manufactured by Akunah Pty, Ltd.. The 510(k) number is K222987.

When was Akunah REFLECT approved by the FDA?

Akunah REFLECT received FDA 510(k) clearance on 2023-05-10, under approval number K222987.

What company makes Akunah REFLECT?

Akunah REFLECT is manufactured by Akunah Pty, Ltd..

What is the FDA product code for Akunah REFLECT?

The FDA product code for Akunah REFLECT 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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