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FDA 510(k)

ANDI

K-Number: K230913 · 2023-07-25

ApplicantImeka Solutions, Inc.
Decision Date2023-07-25
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ANDI is a medical device manufactured by Imeka Solutions, Inc.. It received FDA 510(k) clearance on 2023-07-25 under approval number K230913. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANDI?

ANDI is a medical device that received FDA 510(k) clearance on 2023-07-25. It is manufactured by Imeka Solutions, Inc.. The 510(k) number is K230913.

When was ANDI approved by the FDA?

ANDI received FDA 510(k) clearance on 2023-07-25, under approval number K230913.

What company makes ANDI?

ANDI is manufactured by Imeka Solutions, Inc..

What is the FDA product code for ANDI?

The FDA product code for ANDI is QIH.

Other Devices by Imeka Solutions, Inc.

K252298ANDI 2.0

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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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