FDA 510(k)

STERRAD VELOCITY 生物指示劑/過程挑戰裝置及閱讀器

K 號：K192025 · 2020-01-23

申請人Advanced Sterilization Products (Asp)

決定日期2020-01-23

產品代碼FRC

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

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K192025. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Advanced Sterilization Products (Asp). The 510(k) number is K192025.

When did STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader receive FDA 510(k) clearance?

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader received FDA 510(k) clearance on 2020-01-23, under 510(k) number K192025.

Who is the listed applicant for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

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

What is the FDA product code for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

The FDA product code for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is FRC.

其他以 Advanced Sterilization Products (Asp) 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：FRC）

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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官方來源

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