FDA 510(k)

驗證V24自給式生物指示標誌，驗證V24生物指示標誌挑戰包

K 號：K183300 · 2019-01-03

決定日期2019-01-03

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

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K183300. 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 VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Steris Corporations. The 510(k) number is K183300.

When did VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack receive FDA 510(k) clearance?

VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack received FDA 510(k) clearance on 2019-01-03, under 510(k) number K183300.

Who is the listed applicant for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

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

What is the FDA product code for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack?

The FDA product code for VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack is FRC.

其他以 Steris Corporations 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。

K203630BioGuard 空氣/水及吸引閥 K190104系統1E 液體化學消毒劑處理系統，系統1內鏡液體化學消毒劑處理系統 K183295Celerity HP化學指示標誌（CI）K182931驗證全功能一體式蒸汽可重用測試包，驗證全功能一體式蒸汽可重用測試包附步數計，驗證全功能一體式蒸汽可重用測試包附追蹤標籤 K180342系統1E 液體化學消毒劑處理系統 K172748驗證V24自給式生物指示標誌，驗證V24生物指示標誌挑戰包

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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。

K260766Celerity 5 HP 生物指示標（LCB052）STERIS Corporation K252680Celerity™ 20 HP 生物指示標STERIS Corporation K251122Terragene® Bionova® BT20 生物指示劑Terragene K251452Celerity 5 HP 生物指示標（LCB052）；Celerity 5 HP 挑戰包（LCB059）；Celerity 20 HP 生物指示標（LCB044）；Celerity 20 HP 挑戰包（LCB045）Steris K250061Celerity IncubatorSTERIS Corporation K250044Celerity 5 HP 生物指示標（LCB052）；Celerity 5 HP 挑戰包（LCB059）；Celerity 20 HP 生物指示標（LCB044）；Celerity 20 HP 挑戰包（LCB045）STERIS Corporation

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