FDA 510(k)

美林普通外科用盤

K 號：K213481 · 2022-05-24

決定日期2022-05-24

產品代碼LRO

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

Medline General Surgery Tray is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2022-05-24 under 510(k) number K213481. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medline General Surgery Tray?

Medline General Surgery Tray is a medical device that received FDA 510(k) clearance on 2022-05-24. The listed applicant is Medline Industries, Inc.. The 510(k) number is K213481.

When did Medline General Surgery Tray receive FDA 510(k) clearance?

Medline General Surgery Tray received FDA 510(k) clearance on 2022-05-24, under 510(k) number K213481.

Who is the listed applicant for Medline General Surgery Tray?

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

What is the FDA product code for Medline General Surgery Tray?

The FDA product code for Medline General Surgery Tray is LRO.

其他以 Medline Industries, 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。

K230559Hudson RCI® 一次性加濕器，配4 PSI壓力釋放閥（3230），Hudson RCI® 一次性加濕器，配6 PSI壓力釋放閥（3260）K223100Hudson RCI 水熱 III Plus 外置可調節電熱器 (050-14)K222665Medline UNITE® 頸關節融合板系統 K213054美林確鎖安全針，美林確鎖安全針筒 K212911康尼格摩根夾具 K220565Hudson RCI Triflo II 勸誘深呼吸運動器

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相關器械（代碼：LRO）

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。

K212258Medline 心血管手術套件Medline Industries, Inc.

官方來源

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