免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

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

K 號：K182931 · 2018-11-20

申請人Steris Corporations
決定日期2018-11-20
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 All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2018-11-20 under 510(k) number K182931. 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 All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag?

VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag is a medical device that received FDA 510(k) clearance on 2018-11-20. The listed applicant is Steris Corporations. The 510(k) number is K182931.

When did VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag receive FDA 510(k) clearance?

VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag received FDA 510(k) clearance on 2018-11-20, under 510(k) number K182931.

Who is the listed applicant for VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag?

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 All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag?

The FDA product code for VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag is FRC.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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）K183300驗證V24自給式生物指示標誌，驗證V24生物指示標誌挑戰包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

查看所有 7 項裝置 →

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 CorporationK252680Celerity™ 20 HP 生物指示標STERIS CorporationK251122Terragene® Bionova® BT20 生物指示劑TerrageneK251452Celerity 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）SterisK250061Celerity IncubatorSTERIS CorporationK250044Celerity 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

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑