FDA 510(k)

純淨流外部對抗式壓力泵設備

K 號：K173483 · 2018-05-30

決定日期2018-05-30

產品代碼DRN

諮詢委員會履歷

決定相當於

器材摘要

Pure Flow External Counter-Pulsation Device is the device name listed in this FDA 510(k) record. The listed applicant is Xtreem Pulse, LLC. It received FDA 510(k) clearance on 2018-05-30 under 510(k) number K173483. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pure Flow External Counter-Pulsation Device?

Pure Flow External Counter-Pulsation Device is a medical device that received FDA 510(k) clearance on 2018-05-30. The listed applicant is Xtreem Pulse, LLC. The 510(k) number is K173483.

When did Pure Flow External Counter-Pulsation Device receive FDA 510(k) clearance?

Pure Flow External Counter-Pulsation Device received FDA 510(k) clearance on 2018-05-30, under 510(k) number K173483.

Who is the listed applicant for Pure Flow External Counter-Pulsation Device?

FDA 510(k) 記錄將 Xtreem Pulse, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Pure Flow External Counter-Pulsation Device?

The FDA product code for Pure Flow External Counter-Pulsation Device is DRN.

其他以 Xtreem Pulse, LLC 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。

K262861PureLift Pro Max K243587PureLift GLOW K221443PureLift Pro Plus K190269純昇

相關器械（代碼：DRN）

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。

K250756壓力波 PRO 外部反搏系統Pression, Inc.K202108外部壓力輔助系統，SoulaireVamed Medical Instrument Co., Ltd.K191955強化外部反搏壓設備 Plus Omay-AOmay(Guangzhou)Med Technologies Co., Ltd.K190683外部壓力輔助系統Vamed Medical Instrument Co., Ltd.

官方來源

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