海伯尼特RT
K 號：K151461 · 2016-03-24
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器材摘要
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.
常見問題
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.
相關臨床試驗
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
相關器械（代碼：BZE）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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