FDA 510(k)

3M Attest 蒸發過氧化氫化物三維化學指示劑

K 號：K203284 · 2020-12-07

決定日期2020-12-07

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

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 2020-12-07 under 510(k) number K203284. 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 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator?

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator is a medical device that received FDA 510(k) clearance on 2020-12-07. The listed applicant is 3M Company. The 510(k) number is K203284.

When did 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator receive FDA 510(k) clearance?

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator received FDA 510(k) clearance on 2020-12-07, under 510(k) number K203284.

Who is the listed applicant for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator?

The FDA 510(k) record lists 3M Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator?

The FDA product code for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator is QKM.

其他以 3M Company 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。

K2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M K2425383M® Attest® 超级快速读数生物指示剂 1493；3M® Attest® 超级快速蒸汽重力清晰挑战包 1493PCDG；3M® Attest® 自动读取器 490；3M® Attest® 自动读取器 490H；3M® Attest® 迷你自动读取器 490M K2419593M® Attest® 超级快速蒸汽清晰挑战包 (1492PCD)；3M® Attest® 自动读取器 (490)；3M® Attest® 自动读取器 (490H)；3M® Attest® 迷你自动读取器 (490M)K2417103M® Attest® 超级快速读数生物指示剂 1492V；3M® Attest® 自动读取器 490；3M® Attest® 自动读取器 490H；3M® Attest® 迷你自动读取器 490M K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)K2407173M® Attest® 快速读数生物指示剂 1295 和 3M® Attest® 蒸汽化氢氧化氢三参数化学指示剂 1348/1348E

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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 K213262CELERITY HP 化學指示器STERIS Corporation 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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