FDA 510(k)

STERRAD NX 配備 ALLClear 技術

K 號：K220404 · 2022-05-16

申請人Advanced Sterilization Products, Inc.

決定日期2022-05-16

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 with ALLClear Technology is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products, Inc.. It received FDA 510(k) clearance on 2022-05-16 under 510(k) number K220404. 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 with ALLClear Technology?

STERRAD NX with ALLClear Technology is a medical device that received FDA 510(k) clearance on 2022-05-16. The listed applicant is Advanced Sterilization Products, Inc.. The 510(k) number is K220404.

When did STERRAD NX with ALLClear Technology receive FDA 510(k) clearance?

STERRAD NX with ALLClear Technology received FDA 510(k) clearance on 2022-05-16, under 510(k) number K220404.

Who is the listed applicant for STERRAD NX with ALLClear Technology?

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

What is the FDA product code for STERRAD NX with ALLClear Technology?

The FDA product code for STERRAD NX with ALLClear Technology is MLR.

其他以 Advanced Sterilization Products, 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。

K252843STERRAD 100NX 消毒系統搭配 ALLClear 技術（10104）K250802STERRAD® 100NX 高效滅菌器搭配 ALLClear™ 技術（10104）K234084STERRAD™化學指示劑（CI）條（14100）；STERRAD® SEALSURE®化學指示劑（CI）膠帶（14202NL）；STERRAD VELOCITY™生物指示劑（BI）（43210）（60入）；STERRAD VELOCITY™生物指示劑（BI）（43210-30）（30入）；STERRAD VELOCITY™閱讀器（43220）；ULTRA GI™過程挑戰裝置（PCD）（43400）（30入）K212174STERRAD 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

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。