免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

14Fr 大腸减压設備組,Macon 大腸减压設備組

K 號:K171619 · 2017-08-01

決定日期2017-08-01
產品代碼FEG
諮詢委員會GU
決定相當於

器材摘要

14Fr Colon Decompression Set, Macon Colon Decompression Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K171619. The device is classified under product code FEG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 14Fr Colon Decompression Set, Macon Colon Decompression Set?

14Fr Colon Decompression Set, Macon Colon Decompression Set is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K171619.

When did 14Fr Colon Decompression Set, Macon Colon Decompression Set receive FDA 510(k) clearance?

14Fr Colon Decompression Set, Macon Colon Decompression Set received FDA 510(k) clearance on 2017-08-01, under 510(k) number K171619.

Who is the listed applicant for 14Fr Colon Decompression Set, Macon Colon Decompression Set?

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

What is the FDA product code for 14Fr Colon Decompression Set, Macon Colon Decompression Set?

The FDA product code for 14Fr Colon Decompression Set, Macon Colon Decompression Set is FEG.

相關臨床試驗

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。

其他以 Cook Ireland, Ltd. 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。

查看所有 16 項裝置 →

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。

↑