FDA 510(k)

Akunah REFLECT

K-Number: K222987 · 2023-05-10

Decision Date2023-05-10

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Akunah REFLECT is the device name listed in this FDA 510(k) record. The listed applicant is Akunah Pty, Ltd.. It received FDA 510(k) clearance on 2023-05-10 under 510(k) 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. The listed applicant is Akunah Pty, Ltd.. The 510(k) number is K222987.

When did Akunah REFLECT receive FDA 510(k) clearance?

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

Who is the listed applicant for Akunah REFLECT?

The FDA 510(k) record lists Akunah Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Akunah REFLECT?

The FDA product code for Akunah REFLECT is LLZ.

Related Devices (Code: 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.