FDA 510(k)

塑膠LOR針筒

K 號：K201356 · 2021-02-12

決定日期2021-02-12

產品代碼CAZ

諮詢委員會AN

決定相當於

器材摘要

Plastic LOR Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2021-02-12 under 510(k) number K201356. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Plastic LOR Syringe?

Plastic LOR Syringe is a medical device that received FDA 510(k) clearance on 2021-02-12. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K201356.

When did Plastic LOR Syringe receive FDA 510(k) clearance?

Plastic LOR Syringe received FDA 510(k) clearance on 2021-02-12, under 510(k) number K201356.

Who is the listed applicant for Plastic LOR Syringe?

The FDA 510(k) record lists Jiangsu Caina Medical Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Plastic LOR Syringe?

The FDA product code for Plastic LOR Syringe is CAZ.

其他以 Jiangsu Caina Medical Co.,Ltd 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。

K232781安全滑動血液採集套件 K233190ENFit 轉接器 K230635針筒針 K220184泵對齊針筒 K211593腸內輸液泵針筒 K210217無針連接器

查看所有 15 項裝置 →

相關器械（代碼：CAZ）

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。

K261372Profoject™ LOR 靜脈注射針CMT Health PTE., Ltd.K222341Arrow 0.2 Micron Flat Filter, GVSArrow International, LLC K210983BD Epilor 静脈注射器Becton, Dickinson and Company K202699E-Cath STIM 依照崔氏規範PAJUNK GmbH Medizintechnologie K190345VPCPAJUNK GmbH Medizintechnologie K161075Arrow硬脊膜外針套件Teleflexmedical, Inc.

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。