Decision Date2016-03-24
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Hybernite RT is the device name listed in this FDA 510(k) record. The listed applicant is Plastiflex Group NV. It received FDA 510(k) clearance on 2016-03-24 under 510(k) 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. The listed applicant is Plastiflex Group NV. The 510(k) number is K151461.
When did Hybernite RT receive FDA 510(k) clearance?
Hybernite RT received FDA 510(k) clearance on 2016-03-24, under 510(k) number K151461.
Who is the listed applicant for Hybernite RT?
The FDA 510(k) record lists Plastiflex Group NV as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hybernite RT?
The FDA product code for Hybernite RT is BZE.
Related Devices (Code: BZE)
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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