FDA 510(k)

Hybernite RT

K-Number: K151461 · 2016-03-24

Decision Date2016-03-24

Product CodeBZE

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Hybernite RT is a medical device manufactured by Plastiflex Group NV. It received FDA 510(k) clearance on 2016-03-24 under approval number K151461. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hybernite RT?

Hybernite RT is a medical device that received FDA 510(k) clearance on 2016-03-24. It is manufactured by Plastiflex Group NV. The 510(k) number is K151461.

When was Hybernite RT approved by the FDA?

Hybernite RT received FDA 510(k) clearance on 2016-03-24, under approval number K151461.

What company makes Hybernite RT?

Hybernite RT is manufactured by Plastiflex Group NV.

What is the FDA product code for Hybernite RT?

The FDA product code for Hybernite RT is BZE.

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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.