ASD 口腔器具
K 號：K163580 · 2017-06-08
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器材摘要
ASD Oral Appliances is the device name listed in this FDA 510(k) record. The listed applicant is American Sleep Dentistry. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K163580. 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 ASD Oral Appliances?
ASD Oral Appliances is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is American Sleep Dentistry. The 510(k) number is K163580.
When did ASD Oral Appliances receive FDA 510(k) clearance?
ASD Oral Appliances received FDA 510(k) clearance on 2017-06-08, under 510(k) number K163580.
Who is the listed applicant for ASD Oral Appliances?
The FDA 510(k) record lists American Sleep Dentistry as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ASD Oral Appliances?
The FDA product code for ASD Oral Appliances 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：
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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