FDA 510(k)

睡眠貼片

K 號：K183625 · 2019-10-18

決定日期2019-10-18

產品代碼MNR

諮詢委員會AN

決定相當於

器材摘要

SomnaPatch is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K183625. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SomnaPatch?

SomnaPatch is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Respironics, Inc.. The 510(k) number is K183625.

When did SomnaPatch receive FDA 510(k) clearance?

SomnaPatch received FDA 510(k) clearance on 2019-10-18, under 510(k) number K183625.

Who is the listed applicant for SomnaPatch?

FDA 510(k) 記錄將Respironics, Inc.列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for SomnaPatch?

The FDA product code for SomnaPatch is MNR.

其他以 Respironics, Inc. 為申請人之記錄

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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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