FDA 510(k)

AnapnoGuard 100 呼吸保護系統

K 號：K150157 · 2016-02-16

決定日期2016-02-16

產品代碼BSK

諮詢委員會AN

決定相當於

器材摘要

AnapnoGuard 100 Respiratory Guard System is the device name listed in this FDA 510(k) record. The listed applicant is Hospitech Respiration , Ltd.. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K150157. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AnapnoGuard 100 Respiratory Guard System?

AnapnoGuard 100 Respiratory Guard System is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is Hospitech Respiration , Ltd.. The 510(k) number is K150157.

When did AnapnoGuard 100 Respiratory Guard System receive FDA 510(k) clearance?

AnapnoGuard 100 Respiratory Guard System received FDA 510(k) clearance on 2016-02-16, under 510(k) number K150157.

Who is the listed applicant for AnapnoGuard 100 Respiratory Guard System?

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

What is the FDA product code for AnapnoGuard 100 Respiratory Guard System?

The FDA product code for AnapnoGuard 100 Respiratory Guard System is BSK.

其他以 Hospitech Respiration , Ltd. 為申請人之記錄

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K221477AG100s K180991AG 100s

相關器械（代碼：BSK）

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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官方來源

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