FDA 510(k)

IonoStar Plus

K-Number: K160774 · 2016-08-03

Decision Date2016-08-03

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

IonoStar Plus is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2016-08-03 under 510(k) 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. The listed applicant is Voco GmbH. The 510(k) number is K160774.

When did IonoStar Plus receive FDA 510(k) clearance?

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

Who is the listed applicant for IonoStar Plus?

The FDA 510(k) record lists Voco GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IonoStar Plus?

The FDA product code for IonoStar Plus is EMA.

Other records listing Voco GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: 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.