The AIO Solution 3.0
K-Number: K202068 · 2020-08-14
ApplicantOrfit Industries NV
Decision Date2020-08-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
The AIO Solution 3.0 is a medical device manufactured by Orfit Industries NV. It received FDA 510(k) clearance on 2020-08-14 under approval number K202068. 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 3.0?
The AIO Solution 3.0 is a medical device that received FDA 510(k) clearance on 2020-08-14. It is manufactured by Orfit Industries NV. The 510(k) number is K202068.
When was The AIO Solution 3.0 approved by the FDA?
The AIO Solution 3.0 received FDA 510(k) clearance on 2020-08-14, under approval number K202068.
What company makes The AIO Solution 3.0?
The AIO Solution 3.0 is manufactured by Orfit Industries NV.
What is the FDA product code for The AIO Solution 3.0?
The FDA product code for The AIO Solution 3.0 is IYE.
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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.