我的睡眠達示
K 號：K252338 · 2026-04-17
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器材摘要
MySleepDash is the device name listed in this FDA 510(k) record. The listed applicant is Somnetics International, Inc. (Dba Transcend Inc). It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K252338. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MySleepDash?
MySleepDash is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Somnetics International, Inc. (Dba Transcend Inc). The 510(k) number is K252338.
When did MySleepDash receive FDA 510(k) clearance?
MySleepDash received FDA 510(k) clearance on 2026-04-17, under 510(k) number K252338.
Who is the listed applicant for MySleepDash?
The FDA 510(k) record lists Somnetics International, Inc. (Dba Transcend Inc) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MySleepDash?
The FDA product code for MySleepDash is BZD.
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：BZD）
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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