FDA 510(k)

EzVu視覺血管加壓注射器（EV-19）

K 號：K241595 · 2025-02-27

決定日期2025-02-27

產品代碼FBK

諮詢委員會GU

決定相當於

器材摘要

EzVu Visual Vasopressor injector (EV-19) is the device name listed in this FDA 510(k) record. The listed applicant is Veol Medical Technologies Pvt , Ltd.. It received FDA 510(k) clearance on 2025-02-27 under 510(k) number K241595. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EzVu Visual Vasopressor injector (EV-19)?

EzVu Visual Vasopressor injector (EV-19) is a medical device that received FDA 510(k) clearance on 2025-02-27. The listed applicant is Veol Medical Technologies Pvt , Ltd.. The 510(k) number is K241595.

When did EzVu Visual Vasopressor injector (EV-19) receive FDA 510(k) clearance?

EzVu Visual Vasopressor injector (EV-19) received FDA 510(k) clearance on 2025-02-27, under 510(k) number K241595.

Who is the listed applicant for EzVu Visual Vasopressor injector (EV-19)?

The FDA 510(k) record lists Veol Medical Technologies Pvt , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EzVu Visual Vasopressor injector (EV-19)?

The FDA product code for EzVu Visual Vasopressor injector (EV-19) is FBK.

其他以 Veol Medical Technologies Pvt , 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。

K240205Ez Catch 自動; Ez Catch YR; Ez Catch TR

相關器械（代碼：FBK）

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。

K260262注射針Mirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE 注射系統Carbon Medical Technologies, Inc.K252021一次性內視鏡注射針Changzhou New Med Micro-Medtech Co., Ltd.K252247注射力最大單次使用注射器（NM-400L）；注射力最大單次使用注射器（NM-400U）；注射力最大單次使用注射器（NM-400Y）；注射力最大單次使用注射器（NM-401L）Olympus Medical Systems Corporation K240675內視鏡注射針Promisemed Hangzhou Meditech Co., Ltd.K241523injeTAK可調針尖針筒 (DIS199; DIS201)Laborie Medical Technologies, Corp.

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。