呼吸粉紅AT（硬質，硬質/柔質，EF）
K 號：K192127 · 2020-02-05
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器材摘要
Respire Pink AT (Hard, Hard/Soft, EF) is the device name listed in this FDA 510(k) record. The listed applicant is Respire Medical Holdings. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K192127. 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 Pink AT (Hard, Hard/Soft, EF)?
Respire Pink AT (Hard, Hard/Soft, EF) is a medical device that received FDA 510(k) clearance on 2020-02-05. The listed applicant is Respire Medical Holdings. The 510(k) number is K192127.
When did Respire Pink AT (Hard, Hard/Soft, EF) receive FDA 510(k) clearance?
Respire Pink AT (Hard, Hard/Soft, EF) received FDA 510(k) clearance on 2020-02-05, under 510(k) number K192127.
Who is the listed applicant for Respire Pink AT (Hard, Hard/Soft, EF)?
The FDA 510(k) record lists Respire Medical Holdings as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Respire Pink AT (Hard, Hard/Soft, EF)?
The FDA product code for Respire Pink AT (Hard, Hard/Soft, EF) 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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