FDA 510(k)

驗證蒸汽整合指示器

K 號：K243876 · 2025-04-25

決定日期2025-04-25

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

VERIFY STEAM Integrating Indicator is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243876. 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 VERIFY STEAM Integrating Indicator?

VERIFY STEAM Integrating Indicator is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is STERIS Corporation. The 510(k) number is K243876.

When did VERIFY STEAM Integrating Indicator receive FDA 510(k) clearance?

VERIFY STEAM Integrating Indicator received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243876.

Who is the listed applicant for VERIFY STEAM Integrating Indicator?

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

What is the FDA product code for VERIFY STEAM Integrating Indicator?

The FDA product code for VERIFY STEAM Integrating Indicator is JOJ.

其他以 STERIS Corporation 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。

K261055AMSCO 700 鋰氣滅菌器 K260766Celerity 5 HP 生物指示標（LCB052）K251666系統1E 液體化學消毒劑處理系統，型號P6700；系統1內科液體化學消毒劑處理系統，型號P6900 K252680Celerity™ 20 HP 生物指示標 K251048Rapicide PA 高級消毒試紙模型參考編號 = ML02-0118 K250842鎖形釘 EFTR 套件 (00713229)

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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 K250172綠卡波威-迪克測試（BD115）Steritec Products, Inc. (A Getinge Company)

官方來源

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