FDA 510(k)

TheraView TBI

K-Number: K170058 · 2017-03-03

Decision Date2017-03-03

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TheraView TBI is the device name listed in this FDA 510(k) record. The listed applicant is Cablon Medical B.V.. It received FDA 510(k) clearance on 2017-03-03 under 510(k) 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. The listed applicant is Cablon Medical B.V.. The 510(k) number is K170058.

When did TheraView TBI receive FDA 510(k) clearance?

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

Who is the listed applicant for TheraView TBI?

The FDA 510(k) record lists Cablon Medical B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TheraView TBI?

The FDA product code for TheraView TBI is IYE.

Related Devices (Code: IYE)

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.

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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.