FDA 510(k)

Midmark及Ritter M9和M11 UltraClave®自動滅菌器以及Ritter M9D AutoClave®自動滅菌器

K 號：K163337 · 2017-08-31

決定日期2017-08-31

產品代碼FLE

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Midmark Corporation. It received FDA 510(k) clearance on 2017-08-31 under 510(k) number K163337. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer?

Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Midmark Corporation. The 510(k) number is K163337.

When did Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer receive FDA 510(k) clearance?

Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer received FDA 510(k) clearance on 2017-08-31, under 510(k) number K163337.

Who is the listed applicant for Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer?

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

What is the FDA product code for Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer?

The FDA product code for Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer is FLE.

其他以 Midmark 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。

K253196Midmark 800 電子生命徵象儀器（1-300-0100，1-300-0200，1-300-0300，1-300-0400）K251626美達克牙科輸送系統 K233026Midmark Smart M9® 過濾器，Midmark Smart M11® 過濾器 K201667Midmark 頭外顯影系統 (EOIS)K161909IQvitals區域

相關器械（代碼：FLE）

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。

K261055AMSCO 700 鋰氣滅菌器STERIS Corporation K260254Enbio PROEnbio Group AG K252307Getinge GSS67N系列蒸氣滅菌器Maquet GmbH (A Getinge Group Company)K250168Life Ultra 25L 桌上單室蒸汽滅菌器Lucas Lifecare K250164卡式蒸汽滅菌器（ACA5）Guangzhou Ajax Medical Equipment Co., Ltd.K243994蒸汽滅菌器（2545D）Ningbo Ican Machines Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。