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FDA 510(k)

Erbe ESU Model VIO 3 with Accessories

K-Number: K190823 · 2019-05-22

Decision Date2019-05-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Erbe ESU Model VIO 3 with Accessories is a medical device manufactured by Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2019-05-22 under approval number K190823. 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 3 with Accessories?

Erbe ESU Model VIO 3 with Accessories is a medical device that received FDA 510(k) clearance on 2019-05-22. It is manufactured by Erbe Elektromedizin GmbH. The 510(k) number is K190823.

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

Erbe ESU Model VIO 3 with Accessories received FDA 510(k) clearance on 2019-05-22, under approval number K190823.

What company makes Erbe ESU Model VIO 3 with Accessories?

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

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

The FDA product code for Erbe ESU Model VIO 3 with Accessories 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.