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FDA 510(k)

恩塔里克輸食管系統;恩塔里克輸食管

K 號:K230206 · 2023-03-24

決定日期2023-03-24
產品代碼KNT
諮詢委員會GU
決定相當於

器材摘要

Entarik Feeding Tube System; Entarik Feeding Tube is the device name listed in this FDA 510(k) record. The listed applicant is Gravitas Medical, Inc.. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K230206. 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 Entarik Feeding Tube System; Entarik Feeding Tube?

Entarik Feeding Tube System; Entarik Feeding Tube is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Gravitas Medical, Inc.. The 510(k) number is K230206.

When did Entarik Feeding Tube System; Entarik Feeding Tube receive FDA 510(k) clearance?

Entarik Feeding Tube System; Entarik Feeding Tube received FDA 510(k) clearance on 2023-03-24, under 510(k) number K230206.

Who is the listed applicant for Entarik Feeding Tube System; Entarik Feeding Tube?

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

What is the FDA product code for Entarik Feeding Tube System; Entarik Feeding Tube?

The FDA product code for Entarik Feeding Tube System; Entarik Feeding Tube is KNT.

相關臨床試驗

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其他以 Gravitas Medical, Inc. 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。

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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