TEMPEDY
K 號：K152946 · 2016-09-15
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器材摘要
TEMPEDY is the device name listed in this FDA 510(k) record. The listed applicant is Seiratherm GmbH. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K152946. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the TEMPEDY?
TEMPEDY is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Seiratherm GmbH. The 510(k) number is K152946.
When did TEMPEDY receive FDA 510(k) clearance?
TEMPEDY received FDA 510(k) clearance on 2016-09-15, under 510(k) number K152946.
Who is the listed applicant for TEMPEDY?
The FDA 510(k) record lists Seiratherm GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TEMPEDY?
The FDA product code for TEMPEDY is NCX.
相關臨床試驗
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相關器械（代碼：NCX）
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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