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FDA 510(k)

Erbe ESU Model VIO® 3n with Accessories

K-Number: K251108 · 2025-08-29

ApplicantErbe Elektromedizin GmbH
Decision Date2025-08-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Erbe ESU Model VIO® 3n with Accessories is a medical device manufactured by Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2025-08-29 under approval number K251108. 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 Erbe ESU Model VIO® 3n with Accessories?

Erbe ESU Model VIO® 3n with Accessories is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by Erbe Elektromedizin GmbH. The 510(k) number is K251108.

When was Erbe ESU Model VIO® 3n with Accessories approved by the FDA?

Erbe ESU Model VIO® 3n with Accessories received FDA 510(k) clearance on 2025-08-29, under approval number K251108.

What company makes Erbe ESU Model VIO® 3n with Accessories?

Erbe ESU Model VIO® 3n with Accessories is manufactured by Erbe Elektromedizin GmbH.

What is the FDA product code for Erbe ESU Model VIO® 3n with Accessories?

The FDA product code for Erbe ESU Model VIO® 3n with Accessories is GEI.

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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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