FDA 510(k)

The AIO Solution

K-Number: K191158 · 2019-08-06

Decision Date2019-08-06

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

The AIO Solution is a medical device manufactured by Orfit Industries NV. It received FDA 510(k) clearance on 2019-08-06 under approval number K191158. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The AIO Solution?

The AIO Solution is a medical device that received FDA 510(k) clearance on 2019-08-06. It is manufactured by Orfit Industries NV. The 510(k) number is K191158.

When was The AIO Solution approved by the FDA?

The AIO Solution received FDA 510(k) clearance on 2019-08-06, under approval number K191158.

What company makes The AIO Solution?

The AIO Solution is manufactured by Orfit Industries NV.

What is the FDA product code for The AIO Solution?

The FDA product code for The AIO Solution is IYE.

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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.