FDA 510(k)

WalterLorenz 外科輔助手臂鏡筒固定器

K 號：K190576 · 2019-06-05

決定日期2019-06-05

產品代碼OCV

諮詢委員會GU

決定相當於

器材摘要

WalterLorenz Surgical Assist Arm Scope Holder is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2019-06-05 under 510(k) number K190576. The device is classified under product code OCV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WalterLorenz Surgical Assist Arm Scope Holder?

WalterLorenz Surgical Assist Arm Scope Holder is a medical device that received FDA 510(k) clearance on 2019-06-05. The listed applicant is Biomet Microfixation. The 510(k) number is K190576.

When did WalterLorenz Surgical Assist Arm Scope Holder receive FDA 510(k) clearance?

WalterLorenz Surgical Assist Arm Scope Holder received FDA 510(k) clearance on 2019-06-05, under 510(k) number K190576.

Who is the listed applicant for WalterLorenz Surgical Assist Arm Scope Holder?

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

What is the FDA product code for WalterLorenz Surgical Assist Arm Scope Holder?

The FDA product code for WalterLorenz Surgical Assist Arm Scope Holder is OCV.

其他以 Biomet Microfixation 為申請人之記錄

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相關器械（代碼：OCV）

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。

K240506KARL STORZ 持架Karl Storz Endoscopy America, Inc.K232405ENDOFIX EXO 医療設備規範文本 ENDOFIX EXO 医療設備註冊文獻注意事項：以下翻譯僅根據「medical-regulatory-v1」政策進行，公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別碼和網址等保持原樣。 ENDOFIX EXOAktormed GmbH

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