FDA 510(k)

智慧外引流系統 (Smart External Drain, SED)

K 號：K171586 · 2017-06-30

決定日期2017-06-30

產品代碼JXG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Smart External Drain (SED) System is the device name listed in this FDA 510(k) record. The listed applicant is Aqueduct Critical Care, Inc.. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K171586. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Smart External Drain (SED) System?

Smart External Drain (SED) System is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Aqueduct Critical Care, Inc.. The 510(k) number is K171586.

When did Smart External Drain (SED) System receive FDA 510(k) clearance?

Smart External Drain (SED) System received FDA 510(k) clearance on 2017-06-30, under 510(k) number K171586.

Who is the listed applicant for Smart External Drain (SED) System?

The FDA 510(k) record lists Aqueduct Critical Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart External Drain (SED) System?

The FDA product code for Smart External Drain (SED) System is JXG.

其他以 Aqueduct Critical Care, Inc. 為申請人之記錄

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K181301智慧外引流系統 (Smart External Drain, SED)K172759智慧外引流系統 (Smart External Drain, SED)K161605智慧外引流系統 (Smart External Drain, SED)

相關器械（代碼：JXG）

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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