FDA 510(k)

STERIZONE VP4 測試包

K 號：K203560 · 2021-03-24

決定日期2021-03-24

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

STERIZONE VP4 Test Pack is the device name listed in this FDA 510(k) record. The listed applicant is Tso3 Inc., Now A Part of Stryker. It received FDA 510(k) clearance on 2021-03-24 under 510(k) number K203560. 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 STERIZONE VP4 Test Pack?

STERIZONE VP4 Test Pack is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is Tso3 Inc., Now A Part of Stryker. The 510(k) number is K203560.

When did STERIZONE VP4 Test Pack receive FDA 510(k) clearance?

STERIZONE VP4 Test Pack received FDA 510(k) clearance on 2021-03-24, under 510(k) number K203560.

Who is the listed applicant for STERIZONE VP4 Test Pack?

The FDA 510(k) record lists Tso3 Inc., Now A Part of Stryker as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERIZONE VP4 Test Pack?

The FDA product code for STERIZONE VP4 Test Pack is FRC.

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 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 K250061Celerity IncubatorSTERIS 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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：FRC）

官方來源