FDA 510(k)

FlowMet-R

K 號：K182494 · 2019-02-27

決定日期2019-02-27

產品代碼DPW

諮詢委員會履歷

決定相當於

器材摘要

FlowMet-R is the device name listed in this FDA 510(k) record. The listed applicant is Laser Associated Sciences, Inc.. It received FDA 510(k) clearance on 2019-02-27 under 510(k) number K182494. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FlowMet-R?

FlowMet-R is a medical device that received FDA 510(k) clearance on 2019-02-27. The listed applicant is Laser Associated Sciences, Inc.. The 510(k) number is K182494.

When did FlowMet-R receive FDA 510(k) clearance?

FlowMet-R received FDA 510(k) clearance on 2019-02-27, under 510(k) number K182494.

Who is the listed applicant for FlowMet-R?

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

What is the FDA product code for FlowMet-R?

The FDA product code for FlowMet-R is DPW.

其他以 Laser Associated Sciences, Inc. 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。

K192966FlowMet

相關器械（代碼：DPW）

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。

K260700藍多普血管專家BlueDop Medical, Ltd.K252810FloPatch FP120Flosonics Medical K251904VascuChek 套件、VascuChek 轨射器、VascuChek 醫學探針、VascuChek 聲音基座（VC-KIT-02、VC-TRX-02、VC-CP-01、VC-SD-01）；VascuChek 套件、VascuChek 轨射器、VascuChek 外科探針、VascuChek 聲音基座（VC-KIT-02、VC-TRX-02、VC-SP-01、VC-SD-01）Remington Medical, Inc.K251114FloPatch FP120Flosonics Medical K243852Elfor-LElfi-Tech , Ltd.K241583VascuChek 套件、VascuChek 訊號傳送器、VascuChek 醫學探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-CP-01、VC-CH-01）；VascuChek 套件、VascuChek 訊號傳送器、VascuChek 外科探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-SP-01、VC-CH-01）Remington Medical, 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。