FDA 510(k)

鼾息解

K 號：K170825 · 2017-08-18

決定日期2017-08-18

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

SnoreRx is the device name listed in this FDA 510(k) record. The listed applicant is Apnea Sciences Corporation. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K170825. 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 SnoreRx?

SnoreRx is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Apnea Sciences Corporation. The 510(k) number is K170825.

When did SnoreRx receive FDA 510(k) clearance?

SnoreRx received FDA 510(k) clearance on 2017-08-18, under 510(k) number K170825.

Who is the listed applicant for SnoreRx?

The FDA 510(k) record lists Apnea Sciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SnoreRx?

The FDA product code for SnoreRx is LRK.

其他以 Apnea Sciences Corporation 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。

K153200鼾息解

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。