Iovera 系統
K 號：K211334 · 2021-09-10
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器材摘要
Iovera System is the device name listed in this FDA 510(k) record. The listed applicant is Pacira Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K211334. The device is classified under product code GXH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Iovera System?
Iovera System is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Pacira Pharmaceuticals, Inc.. The 510(k) number is K211334.
When did Iovera System receive FDA 510(k) clearance?
Iovera System received FDA 510(k) clearance on 2021-09-10, under 510(k) number K211334.
Who is the listed applicant for Iovera System?
The FDA 510(k) record lists Pacira Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Iovera System?
The FDA product code for Iovera System is GXH.
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：GXH）
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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