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FDA 510(k)

CORTRAK* 2 腹腔內進入系統 (20-0950)

K 號:K240965 · 2024-06-06

決定日期2024-06-06
產品代碼KNT
諮詢委員會GU
決定相當於

器材摘要

CORTRAK* 2 Enteral Access System (20-0950) is the device name listed in this FDA 510(k) record. The listed applicant is Avanos Medical, Inc.. It received FDA 510(k) clearance on 2024-06-06 under 510(k) number K240965. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CORTRAK* 2 Enteral Access System (20-0950)?

CORTRAK* 2 Enteral Access System (20-0950) is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Avanos Medical, Inc.. The 510(k) number is K240965.

When did CORTRAK* 2 Enteral Access System (20-0950) receive FDA 510(k) clearance?

CORTRAK* 2 Enteral Access System (20-0950) received FDA 510(k) clearance on 2024-06-06, under 510(k) number K240965.

Who is the listed applicant for CORTRAK* 2 Enteral Access System (20-0950)?

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

What is the FDA product code for CORTRAK* 2 Enteral Access System (20-0950)?

The FDA product code for CORTRAK* 2 Enteral Access System (20-0950) is KNT.

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其他以 Avanos Medical, Inc. 為申請人之記錄

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相關器械(代碼:KNT)

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。

官方來源

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