FDA 510(k)

STERRAD NX 過濾器，STERRAD 100NX 過濾器

K 號：K151725 · 2016-01-13

決定日期2016-01-13

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

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K151725. 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 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer?

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Advanced Sterilization Products. The 510(k) number is K151725.

When did STERRAD NX Sterilizer, STERRAD 100NX Sterilizer receive FDA 510(k) clearance?

STERRAD NX Sterilizer, STERRAD 100NX Sterilizer received FDA 510(k) clearance on 2016-01-13, under 510(k) number K151725.

Who is the listed applicant for STERRAD NX Sterilizer, STERRAD 100NX Sterilizer?

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

What is the FDA product code for STERRAD NX Sterilizer, STERRAD 100NX Sterilizer?

The FDA product code for STERRAD NX Sterilizer, STERRAD 100NX Sterilizer is MLR.

其他以 Advanced Sterilization Products 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。

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)K163598泰維克自封袋含STERRAD化學指示劑，泰維克卷材含STERRAD化學指示劑，泰維克熱封袋含STERRAD化學指示劑 K162007STERRAD NX 過濾器 K160818STERRAD® NX 高效滅菌器配備 ALLClear™ 技術 K160903STERRAD 100NX 消毒器，配備 ALLClear™ 技術

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.K233065V-PRO maX 2 低溫消毒系統Steris

官方來源

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