呼吸淨化器
K 號：K214096 · 2022-05-31
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器材摘要
Respire Clear is the device name listed in this FDA 510(k) record. The listed applicant is Respire Medical, LLC. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K214096. 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 Respire Clear?
Respire Clear is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Respire Medical, LLC. The 510(k) number is K214096.
When did Respire Clear receive FDA 510(k) clearance?
Respire Clear received FDA 510(k) clearance on 2022-05-31, under 510(k) number K214096.
Who is the listed applicant for Respire Clear?
The FDA 510(k) record lists Respire Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Respire Clear?
The FDA product code for Respire Clear 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
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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