FDA 510(k)

JiveX (Model Number / Release: 5.3)

K-Number: K212321 · 2021-09-23

Decision Date2021-09-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

JiveX (Model Number / Release: 5.3) is a medical device manufactured by Visus Health IT GmbH. It received FDA 510(k) clearance on 2021-09-23 under approval number K212321. 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 (Model Number / Release: 5.3)?

JiveX (Model Number / Release: 5.3) is a medical device that received FDA 510(k) clearance on 2021-09-23. It is manufactured by Visus Health IT GmbH. The 510(k) number is K212321.

When was JiveX (Model Number / Release: 5.3) approved by the FDA?

JiveX (Model Number / Release: 5.3) received FDA 510(k) clearance on 2021-09-23, under approval number K212321.

What company makes JiveX (Model Number / Release: 5.3)?

JiveX (Model Number / Release: 5.3) is manufactured by Visus Health IT GmbH.

What is the FDA product code for JiveX (Model Number / Release: 5.3)?

The FDA product code for JiveX (Model Number / Release: 5.3) is LLZ.

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Other Devices by Visus Health IT GmbH

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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.