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FDA 510(k)

IonoStar Plus

K-Number: K160774 · 2016-08-03

ApplicantVoco GmbH
Decision Date2016-08-03
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IonoStar Plus is a medical device manufactured by Voco GmbH. It received FDA 510(k) clearance on 2016-08-03 under approval number K160774. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IonoStar Plus?

IonoStar Plus is a medical device that received FDA 510(k) clearance on 2016-08-03. It is manufactured by Voco GmbH. The 510(k) number is K160774.

When was IonoStar Plus approved by the FDA?

IonoStar Plus received FDA 510(k) clearance on 2016-08-03, under approval number K160774.

What company makes IonoStar Plus?

IonoStar Plus is manufactured by Voco GmbH.

What is the FDA product code for IonoStar Plus?

The FDA product code for IonoStar Plus is EMA.

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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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