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FDA 510(k)

Reverso

K-Number: K212107 · 2021-11-10

ApplicantIntelis Instruments , Ltd.
Decision Date2021-11-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Reverso is a medical device manufactured by Intelis Instruments , Ltd.. It received FDA 510(k) clearance on 2021-11-10 under approval number K212107. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reverso?

Reverso is a medical device that received FDA 510(k) clearance on 2021-11-10. It is manufactured by Intelis Instruments , Ltd.. The 510(k) number is K212107.

When was Reverso approved by the FDA?

Reverso received FDA 510(k) clearance on 2021-11-10, under approval number K212107.

What company makes Reverso?

Reverso is manufactured by Intelis Instruments , Ltd..

What is the FDA product code for Reverso?

The FDA product code for Reverso is GEI.

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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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