FDA 510(k)

斯泰克淨注射器

K 號：K200242 · 2020-07-27

決定日期2020-07-27

產品代碼QLY

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

StaClear Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Tribofilm Research, Inc.. It received FDA 510(k) clearance on 2020-07-27 under 510(k) number K200242. The device is classified under product code QLY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the StaClear Syringe?

StaClear Syringe is a medical device that received FDA 510(k) clearance on 2020-07-27. The listed applicant is Tribofilm Research, Inc.. The 510(k) number is K200242.

When did StaClear Syringe receive FDA 510(k) clearance?

StaClear Syringe received FDA 510(k) clearance on 2020-07-27, under 510(k) number K200242.

Who is the listed applicant for StaClear Syringe?

The FDA 510(k) record lists Tribofilm Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StaClear Syringe?

The FDA product code for StaClear Syringe is QLY.

相關器械（代碼：QLY）

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。

K251849StaClear 静脈注射器（SC250AN）；StaClear 静脈注射器（SC250LS）；StaClear 静脈注射器（SC250LL）Staclear, Inc.K243322Altaviz Intravitreal SyringeAltaviz, LLC K243027可棄式水質濃縮收集器（SnovoDAHC I-50、SnovoDAHC II-50、SnovoDAHC II-50-27、SnovoDAHC II-100-27）Hangzhou Sightnovo Medical Technology Co., Ltd.K243936StaClear 静脈注射器（SC250AN）；StaClear 静脈注射器（SC250LS）；StaClear 静脈注射器（SC250LL）Staclear, Inc.K243149微升注射器（9、20、25、37.5、50及100微升型號）Congruence Medical Solutions, LLC K230372維特賈克針筒Ocuject, LLC

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：QLY）

官方來源