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FDA 510(k)

胃光導管(GLG)

K 號:K212407 · 2022-07-26

決定日期2022-07-26
產品代碼KNT
諮詢委員會GU
決定相當於

器材摘要

Gastric Lightguide (GLG) is the device name listed in this FDA 510(k) record. The listed applicant is Naser Dib Gabinet Lekarksi Nasmed. It received FDA 510(k) clearance on 2022-07-26 under 510(k) number K212407. 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 Gastric Lightguide (GLG)?

Gastric Lightguide (GLG) is a medical device that received FDA 510(k) clearance on 2022-07-26. The listed applicant is Naser Dib Gabinet Lekarksi Nasmed. The 510(k) number is K212407.

When did Gastric Lightguide (GLG) receive FDA 510(k) clearance?

Gastric Lightguide (GLG) received FDA 510(k) clearance on 2022-07-26, under 510(k) number K212407.

Who is the listed applicant for Gastric Lightguide (GLG)?

The FDA 510(k) record lists Naser Dib Gabinet Lekarksi Nasmed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gastric Lightguide (GLG)?

The FDA product code for Gastric Lightguide (GLG) is KNT.

相關臨床試驗

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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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