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FDA 510(k)

TheraView TBI

K-Number: K170058 · 2017-03-03

ApplicantCablon Medical B.V.
Decision Date2017-03-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TheraView TBI is a medical device manufactured by Cablon Medical B.V.. It received FDA 510(k) clearance on 2017-03-03 under approval number K170058. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TheraView TBI?

TheraView TBI is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Cablon Medical B.V.. The 510(k) number is K170058.

When was TheraView TBI approved by the FDA?

TheraView TBI received FDA 510(k) clearance on 2017-03-03, under approval number K170058.

What company makes TheraView TBI?

TheraView TBI is manufactured by Cablon Medical B.V..

What is the FDA product code for TheraView TBI?

The FDA product code for TheraView TBI is IYE.

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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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