體溫軟體 (BTS)
K 號：K243778 · 2025-02-13
廣告
申請人Fitbit, LLC
決定日期2025-02-13
產品代碼QZA
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
Body Temperature Software (BTS) is the device name listed in this FDA 510(k) record. The listed applicant is Fitbit, LLC. It received FDA 510(k) clearance on 2025-02-13 under 510(k) number K243778. The device is classified under product code QZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Body Temperature Software (BTS)?
Body Temperature Software (BTS) is a medical device that received FDA 510(k) clearance on 2025-02-13. The listed applicant is Fitbit, LLC. The 510(k) number is K243778.
When did Body Temperature Software (BTS) receive FDA 510(k) clearance?
Body Temperature Software (BTS) received FDA 510(k) clearance on 2025-02-13, under 510(k) number K243778.
Who is the listed applicant for Body Temperature Software (BTS)?
The FDA 510(k) record lists Fitbit, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Body Temperature Software (BTS)?
The FDA product code for Body Temperature Software (BTS) is QZA.
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。
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