UniPrime A、UniPrime E、UniPrime E/C
K 號：K221033 · 2022-07-06
廣告
器材摘要
UniPrime A, UniPrime E, UniPrime E/C is the device name listed in this FDA 510(k) record. The listed applicant is S&C Polymer Silicon- Und Composite Spezialitäten GmbH. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K221033. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the UniPrime A, UniPrime E, UniPrime E/C?
UniPrime A, UniPrime E, UniPrime E/C is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is S&C Polymer Silicon- Und Composite Spezialitäten GmbH. The 510(k) number is K221033.
When did UniPrime A, UniPrime E, UniPrime E/C receive FDA 510(k) clearance?
UniPrime A, UniPrime E, UniPrime E/C received FDA 510(k) clearance on 2022-07-06, under 510(k) number K221033.
Who is the listed applicant for UniPrime A, UniPrime E, UniPrime E/C?
The FDA 510(k) record lists S&C Polymer Silicon- Und Composite Spezialitäten GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UniPrime A, UniPrime E, UniPrime E/C?
The FDA product code for UniPrime A, UniPrime E, UniPrime E/C is KLE.
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：KLE）
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。
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。
廣告