Express 4 Sleep 裝置/CPAP Sidekick 裝置
K 號：K173856 · 2018-06-26
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器材摘要
Express 4 Sleep appliance/CPAP Sidekick appliance is the device name listed in this FDA 510(k) record. The listed applicant is Moses Appliances, LLC. It received FDA 510(k) clearance on 2018-06-26 under 510(k) number K173856. 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 Express 4 Sleep appliance/CPAP Sidekick appliance?
Express 4 Sleep appliance/CPAP Sidekick appliance is a medical device that received FDA 510(k) clearance on 2018-06-26. The listed applicant is Moses Appliances, LLC. The 510(k) number is K173856.
When did Express 4 Sleep appliance/CPAP Sidekick appliance receive FDA 510(k) clearance?
Express 4 Sleep appliance/CPAP Sidekick appliance received FDA 510(k) clearance on 2018-06-26, under 510(k) number K173856.
Who is the listed applicant for Express 4 Sleep appliance/CPAP Sidekick appliance?
The FDA 510(k) record lists Moses Appliances, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Express 4 Sleep appliance/CPAP Sidekick appliance?
The FDA product code for Express 4 Sleep appliance/CPAP Sidekick appliance is LRK.
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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：
ShaeferH醫療設備，FDA認證，510(k)許可，PMA許可，NCT實驗編號，PMID文獻編號，識別碼及網址。
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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