FDA 510(k)

AG100s

K 號：K221477 · 2022-12-29

決定日期2022-12-29

產品代碼BSK

諮詢委員會AN

決定相當於

器材摘要

AG100s 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 2022-12-29 under 510(k) number K221477. 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 AG100s?

AG100s is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Hospitech Respiration , Ltd.. The 510(k) number is K221477.

When did AG100s receive FDA 510(k) clearance?

AG100s received FDA 510(k) clearance on 2022-12-29, under 510(k) number K221477.

Who is the listed applicant for AG100s?

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 AG100s?

The FDA product code for AG100s is BSK.

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

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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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