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FDA 510(k)

Voyant System

K-Number: K191579 · 2019-07-11

ApplicantViseon, Inc.
Decision Date2019-07-11
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Voyant System is a medical device manufactured by Viseon, Inc.. It received FDA 510(k) clearance on 2019-07-11 under approval number K191579. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Voyant System?

Voyant System is a medical device that received FDA 510(k) clearance on 2019-07-11. It is manufactured by Viseon, Inc.. The 510(k) number is K191579.

When was Voyant System approved by the FDA?

Voyant System received FDA 510(k) clearance on 2019-07-11, under approval number K191579.

What company makes Voyant System?

Voyant System is manufactured by Viseon, Inc..

What is the FDA product code for Voyant System?

The FDA product code for Voyant System is HRX.

Other Devices by Viseon, Inc.

K181885Voyant System

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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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