睡眠APP
K 號：K182202 · 2019-01-11
廣告
器材摘要
SLEEPAPP is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Acrylics, Inc.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K182202. 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 SLEEPAPP?
SLEEPAPP is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Comfort Acrylics, Inc.. The 510(k) number is K182202.
When did SLEEPAPP receive FDA 510(k) clearance?
SLEEPAPP received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182202.
Who is the listed applicant for SLEEPAPP?
The FDA 510(k) record lists Comfort Acrylics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SLEEPAPP?
The FDA product code for SLEEPAPP is LRK.
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：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。
K262104防鼾口器（L09-BB、L09-PP、L09-TB、L09-BT、L09-TP、L09-PT、L09-TT）Ram.Shaw Pte., Ltd.K261912SnøreNegatØr
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
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。
廣告