FDA 510(k)

AIO Breathe

K 號：K252525 · 2025-11-06

決定日期2025-11-06

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

AIO Breathe is the device name listed in this FDA 510(k) record. The listed applicant is Aiomega, LLC. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K252525. 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 AIO Breathe?

AIO Breathe is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Aiomega, LLC. The 510(k) number is K252525.

When did AIO Breathe receive FDA 510(k) clearance?

AIO Breathe received FDA 510(k) clearance on 2025-11-06, under 510(k) number K252525.

Who is the listed applicant for AIO Breathe?

The FDA 510(k) record lists Aiomega, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIO Breathe?

The FDA product code for AIO Breathe is LRK.

其他以 Aiomega, LLC 為申請人之記錄

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。

K233754AIO Breathe

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, LLC K261366VirtusSomnomed, Inc.K261251Snorbliss® 阻止打鼾設備Endeavor Commerce, LLC K261134Dormiva 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。