FDA 510(k)

區域特定目標區域

K 號：K220186 · 2022-05-13

決定日期2022-05-13

產品代碼GAT

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Zone Specific AIM is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K220186. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zone Specific AIM?

Zone Specific AIM is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Conmed Corporation. The 510(k) number is K220186.

When did Zone Specific AIM receive FDA 510(k) clearance?

Zone Specific AIM received FDA 510(k) clearance on 2022-05-13, under 510(k) number K220186.

Who is the listed applicant for Zone Specific AIM?

The FDA 510(k) record lists Conmed Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zone Specific AIM?

The FDA product code for Zone Specific AIM is GAT.

其他以 Conmed Corporation 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。

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相關器械（代碼：GAT）

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。

K253910釘線 - 緝合針線及膠帶GM Dos Reis Industria e Comercio Ltda.K261021EasyWhip 家族Winter Innovations, Inc.K260775聚乙烯；聚乙烯融合；聚乙烯正骨膠帶™Teleflex Medical, LLC K254275超縫全綠延伸線Threadstone, LLC K254188半月板VersaflexGM Dos Reis Industria e Comercio Ltda.K253145預縫合腱Rti Surgical, Inc.

官方來源

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