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FDA 510(k)

Reverso Pro System

K-Number: K243139 · 2025-01-22

ApplicantIndiba S. A. U.
Decision Date2025-01-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Reverso Pro System is a medical device manufactured by Indiba S. A. U.. It received FDA 510(k) clearance on 2025-01-22 under approval number K243139. 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 Pro System?

Reverso Pro System is a medical device that received FDA 510(k) clearance on 2025-01-22. It is manufactured by Indiba S. A. U.. The 510(k) number is K243139.

When was Reverso Pro System approved by the FDA?

Reverso Pro System received FDA 510(k) clearance on 2025-01-22, under approval number K243139.

What company makes Reverso Pro System?

Reverso Pro System is manufactured by Indiba S. A. U..

What is the FDA product code for Reverso Pro System?

The FDA product code for Reverso Pro System is GEI.

Other Devices by Indiba S. A. U.

K243164INDIBA COMPACT devices K241107Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)

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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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