FDA 510(k)

CELERITY HP 化學指示器

K 號：K213262 · 2022-01-07

決定日期2022-01-07

產品代碼QKM

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 Chemical 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 2022-01-07 under 510(k) number K213262. The device is classified under product code QKM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CELERITY HP Chemical Indicator?

CELERITY HP Chemical Indicator is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is STERIS Corporation. The 510(k) number is K213262.

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

CELERITY HP Chemical Indicator received FDA 510(k) clearance on 2022-01-07, under 510(k) number K213262.

Who is the listed applicant for CELERITY HP Chemical 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 CELERITY HP Chemical Indicator?

The FDA product code for CELERITY HP Chemical Indicator is QKM.

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。

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相關器械（代碼：QKM）

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。

K232103Terragene® Chemdye® 多變化學指標 (CD40)，Terragene® Chemdye® 化學製程指標 (CD42)，Terragene® Cintape® 化學製程指標膠帶 (CT40)Terragene S.A.K2120223M Attest 離子化過氧化氫三重指標化學指示標誌 1348/1348E3M Company K2032843M Attest 蒸發過氧化氫化物三維化學指示劑3M Company K1931103M Attest 離子化過氧化氫三重指標化學指示標誌 1348/1348E3M Healthcare

官方來源

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