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FDA 510(k)

AMT G-Tube 气囊胃造口輸食設備

K 號:K222846 · 2023-12-18

決定日期2023-12-18
產品代碼KNT
諮詢委員會GU
決定相當於

器材摘要

AMT G-Tube Balloon Gastrostomy Feeding Device is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-12-18 under 510(k) number K222846. 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 AMT G-Tube Balloon Gastrostomy Feeding Device?

AMT G-Tube Balloon Gastrostomy Feeding Device is a medical device that received FDA 510(k) clearance on 2023-12-18. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K222846.

When did AMT G-Tube Balloon Gastrostomy Feeding Device receive FDA 510(k) clearance?

AMT G-Tube Balloon Gastrostomy Feeding Device received FDA 510(k) clearance on 2023-12-18, under 510(k) number K222846.

Who is the listed applicant for AMT G-Tube Balloon Gastrostomy Feeding Device?

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

What is the FDA product code for AMT G-Tube Balloon Gastrostomy Feeding Device?

The FDA product code for AMT G-Tube Balloon Gastrostomy Feeding Device is KNT.

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其他以 Applied Medical Technology, Inc. 為申請人之記錄

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相關器械(代碼:KNT)

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