FDA 510(k)

AN85/AN86 EO 指示器

K 號：K170426 · 2017-10-30

決定日期2017-10-30

產品代碼JOJ

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

AN85/AN86 EO Indicators is the device name listed in this FDA 510(k) record. The listed applicant is Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K170426. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AN85/AN86 EO Indicators?

AN85/AN86 EO Indicators is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Andersen Sterilizers, Inc.. The 510(k) number is K170426.

When did AN85/AN86 EO Indicators receive FDA 510(k) clearance?

AN85/AN86 EO Indicators received FDA 510(k) clearance on 2017-10-30, under 510(k) number K170426.

Who is the listed applicant for AN85/AN86 EO Indicators?

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

What is the FDA product code for AN85/AN86 EO Indicators?

The FDA product code for AN85/AN86 EO Indicators is JOJ.

其他以 Andersen Sterilizers, 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。

K213296Anprolene SteriTest RRBI K202879EOGas 4 結腸-菌種測試 RRBI K200334AN1036 創射計 K192978EOGas 4 乙烯氧化物氣體消毒器 K200336泰維克滅菌袋，配斜紋封口 K200335斯泰里斯heet 消毒包覆材

查看所有 13 項裝置 →

相關器械（代碼：JOJ）

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。

K2619923M™ Attest™ 蒸氣化學整合器 (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC K260181蒸汽滅菌過程指示膠帶Intertape Polymer Group K251991安全穩定蒸氣消毒過程指示器（4012、4013、4014、4016）；安全穩定氣化過氧化氫消毒過程指示器（4211、4212、4213）Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA 測試條Serim Research K251048Rapicide PA 高級消毒試紙模型參考編號 = ML02-0118STERIS Corporation K243876驗證蒸汽整合指示器STERIS Corporation

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。