FDA 510(k)

CELERITY HP 指示膠帶

K 號：K240760 · 2024-04-10

申請人Steris

決定日期2024-04-10

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

CELERITY HP Indicator Tape is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2024-04-10 under 510(k) number K240760. 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 CELERITY HP Indicator Tape?

CELERITY HP Indicator Tape is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is Steris. The 510(k) number is K240760.

When did CELERITY HP Indicator Tape receive FDA 510(k) clearance?

CELERITY HP Indicator Tape received FDA 510(k) clearance on 2024-04-10, under 510(k) number K240760.

Who is the listed applicant for CELERITY HP Indicator Tape?

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

What is the FDA product code for CELERITY HP Indicator Tape?

The FDA product code for CELERITY HP Indicator Tape is JOJ.

其他以 Steris 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。

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查看所有 19 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

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