TOTIM 患者墊固定系統
K 號：K190894 · 2019-04-30
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器材摘要
TOTIM Patient Cushion Immobilization System is the device name listed in this FDA 510(k) record. The listed applicant is Essebi Medical Srl. It received FDA 510(k) clearance on 2019-04-30 under 510(k) number K190894. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TOTIM Patient Cushion Immobilization System?
TOTIM Patient Cushion Immobilization System is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Essebi Medical Srl. The 510(k) number is K190894.
When did TOTIM Patient Cushion Immobilization System receive FDA 510(k) clearance?
TOTIM Patient Cushion Immobilization System received FDA 510(k) clearance on 2019-04-30, under 510(k) number K190894.
Who is the listed applicant for TOTIM Patient Cushion Immobilization System?
The FDA 510(k) record lists Essebi Medical Srl as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TOTIM Patient Cushion Immobilization System?
The FDA product code for TOTIM Patient Cushion Immobilization System is IYE.
相關臨床試驗
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相關器械（代碼：IYE）
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。
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