FDA 510(k)

V-PRO maX 2 低溫消毒系統

K 號：K233065 · 2023-10-20

申請人Steris

決定日期2023-10-20

產品代碼MLR

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

V-PRO maX 2 Low Temperature Sterilization System is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K233065. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the V-PRO maX 2 Low Temperature Sterilization System?

V-PRO maX 2 Low Temperature Sterilization System is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Steris. The 510(k) number is K233065.

When did V-PRO maX 2 Low Temperature Sterilization System receive FDA 510(k) clearance?

V-PRO maX 2 Low Temperature Sterilization System received FDA 510(k) clearance on 2023-10-20, under 510(k) number K233065.

Who is the listed applicant for V-PRO maX 2 Low Temperature Sterilization System?

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

What is the FDA product code for V-PRO maX 2 Low Temperature Sterilization System?

The FDA product code for V-PRO maX 2 Low Temperature Sterilization System is MLR.

其他以 Steris 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：MLR）

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。

K252843STERRAD 100NX 消毒系統搭配 ALLClear 技術（10104）Advanced Sterilization Products, Inc.K250802STERRAD® 100NX 高效滅菌器搭配 ALLClear™ 技術（10104）Advanced Sterilization Products, Inc.K231893LOWTEM 晶體 120Lowtem Co., Ltd.K234082STERRAD® 100NX 消毒器搭配 ALLClear™ 技術及 ULTRA GI™ 循環 (10104)；APTIMAX™ 裝置盤適用於 ULTRA GI™ 循環 (011077)Advanced Sterilization Products K233762Stereoscope® 過濾技術系統Ideate Medical, Inc.K223476V-PRO maX 2 低溫消毒系統STERIS Corporation

官方來源

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