FDA 510(k)

JiveX

K-Number: K200703 · 2020-04-14

Decision Date2020-04-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

JiveX is the device name listed in this FDA 510(k) record. The listed applicant is Visus Health IT GmbH. It received FDA 510(k) clearance on 2020-04-14 under 510(k) number K200703. 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 2020-04-14. The listed applicant is Visus Health IT GmbH. The 510(k) number is K200703.

When did JiveX receive FDA 510(k) clearance?

JiveX received FDA 510(k) clearance on 2020-04-14, under 510(k) number K200703.

Who is the listed applicant for JiveX?

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

What is the FDA product code for JiveX?

The FDA product code for JiveX is LLZ.

Other records listing Visus Health IT 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.

K231041JiveX (Model Number / Release: 5.4)K212321JiveX (Model Number / Release: 5.3)K181964JiveX

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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.