FDA 510(k)

Sterilucent HC 80TT 氢過氧醯消毒器

K 號：K190005 · 2019-09-13

決定日期2019-09-13

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

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Sterilucent, Inc.. It received FDA 510(k) clearance on 2019-09-13 under 510(k) number K190005. 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 Sterilucent HC 80TT Hydrogen Peroxide Sterilizer?

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Sterilucent, Inc.. The 510(k) number is K190005.

When did Sterilucent HC 80TT Hydrogen Peroxide Sterilizer receive FDA 510(k) clearance?

Sterilucent HC 80TT Hydrogen Peroxide Sterilizer received FDA 510(k) clearance on 2019-09-13, under 510(k) number K190005.

Who is the listed applicant for Sterilucent HC 80TT Hydrogen Peroxide Sterilizer?

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

What is the FDA product code for Sterilucent HC 80TT Hydrogen Peroxide Sterilizer?

The FDA product code for Sterilucent HC 80TT Hydrogen Peroxide Sterilizer is MLR.

其他以 Sterilucent, 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。

K192001自含式生物指示器，Sterilucent 濾光循環過程挑戰裝置，Sterilucent 柔性循環過程挑戰裝置 K191999Sterilucent VH2O2 化學指示劑

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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