FDA 510(k)

視全低溫消毒袋/管，PRO-LITE消毒托盤

K 號：K222440 · 2022-09-09

申請人Steris

決定日期2022-09-09

產品代碼FRG

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

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2022-09-09 under 510(k) number K222440. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays?

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays is a medical device that received FDA 510(k) clearance on 2022-09-09. The listed applicant is Steris. The 510(k) number is K222440.

When did Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays receive FDA 510(k) clearance?

Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays received FDA 510(k) clearance on 2022-09-09, under 510(k) number K222440.

Who is the listed applicant for Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays?

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 Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays?

The FDA product code for Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays is FRG.

其他以 Steris 為申請人之記錄

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相關器械（代碼：FRG）

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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