Twilite 器具
K 號：K190687 · 2019-07-02
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器材摘要
Twilite Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Stephen J Harkins, Dds, PC. It received FDA 510(k) clearance on 2019-07-02 under 510(k) number K190687. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Twilite Appliance?
Twilite Appliance is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Stephen J Harkins, Dds, PC. The 510(k) number is K190687.
When did Twilite Appliance receive FDA 510(k) clearance?
Twilite Appliance received FDA 510(k) clearance on 2019-07-02, under 510(k) number K190687.
Who is the listed applicant for Twilite Appliance?
The FDA 510(k) record lists Stephen J Harkins, Dds, PC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Twilite Appliance?
The FDA product code for Twilite Appliance is LRK.
相關臨床試驗
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相關器械（代碼：LRK）
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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注意：此翻譯僅根據給定的文本進行，並未考慮到專業醫療設備規範文本的完整性和細節。在實際應用中，請確保翻譯符合相關醫療設備規範要求。DnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® 阻止打鼾設備Endeavor Commerce, LLCK261134Dormiva 防打鼾口器Koncept Innovators, Inc.K252942ShaeferH
醫療設備規範文本翻譯：
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注意：公司名稱、產品名稱、FDA、510(k)、PMA、NCT、PMID、識別碼和網址等均未進行翻譯，以保留原文。Shaeferh, LLC
官方來源
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