基礎-IQ技術
K 號：K193483 · 2020-02-28
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器材摘要
Basal-IQ Technology is the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K193483. The device is classified under product code QJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Basal-IQ Technology?
Basal-IQ Technology is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K193483.
When did Basal-IQ Technology receive FDA 510(k) clearance?
Basal-IQ Technology received FDA 510(k) clearance on 2020-02-28, under 510(k) number K193483.
Who is the listed applicant for Basal-IQ Technology?
The FDA 510(k) record lists Tandem Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Basal-IQ Technology?
The FDA product code for Basal-IQ Technology is QJS.
相關臨床試驗
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其他以 Tandem Diabetes Care, Inc. 為申請人之記錄
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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