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FDA 510(k)

JiveX

K-Number: K181964 · 2018-10-23

ApplicantVisus Health IT GmbH
Decision Date2018-10-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

JiveX is a medical device manufactured by Visus Health IT GmbH. It received FDA 510(k) clearance on 2018-10-23 under approval number K181964. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JiveX?

JiveX is a medical device that received FDA 510(k) clearance on 2018-10-23. It is manufactured by Visus Health IT GmbH. The 510(k) number is K181964.

When was JiveX approved by the FDA?

JiveX received FDA 510(k) clearance on 2018-10-23, under approval number K181964.

What company makes JiveX?

JiveX is manufactured by Visus Health IT GmbH.

What is the FDA product code for JiveX?

The FDA product code for JiveX is LLZ.

Other Devices by Visus Health IT GmbH

K200703JiveX K212321JiveX (Model Number / Release: 5.3) K231041JiveX (Model Number / Release: 5.4)

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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.

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