Soberlink 行動裝置及 Sober Sky 網路入口
K 號：K160613 · 2016-07-14
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決定日期2016-07-14
產品代碼DJZ
諮詢委員會此醫療器材法規描述涉及FDA、510(k)、PMA、NCT、PMID及相關網址，以下為繁體中文翻譯：
本醫療器材之監管狀態係依據美國食品藥物管理局（FDA）之相關規定，包括510(k)上市前通知及PMA上市前核准程序。相關臨床試驗資訊可參閱NCT編號及PMID文獻編號，詳細資料請見所附網址。
決定相當於
器材摘要
Soberlink Cellular Device and Sober Sky Web Portal is the device name listed in this FDA 510(k) record. The listed applicant is Soberlink Healthcare, LLC. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K160613. The device is classified under product code DJZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Soberlink Cellular Device and Sober Sky Web Portal?
Soberlink Cellular Device and Sober Sky Web Portal is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Soberlink Healthcare, LLC. The 510(k) number is K160613.
When did Soberlink Cellular Device and Sober Sky Web Portal receive FDA 510(k) clearance?
Soberlink Cellular Device and Sober Sky Web Portal received FDA 510(k) clearance on 2016-07-14, under 510(k) number K160613.
Who is the listed applicant for Soberlink Cellular Device and Sober Sky Web Portal?
The FDA 510(k) record lists Soberlink Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Soberlink Cellular Device and Sober Sky Web Portal?
The FDA product code for Soberlink Cellular Device and Sober Sky Web Portal is DJZ.
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。
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