Hybernite RT
K号: K151461 · 2016-03-24
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决定日期2016-03-24
产品代码BZE
咨询委员会AN
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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相关器械（代码：BZE）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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