FDA 510(k)

超視覺2診斷超音波系統

K 號：K173265 · 2017-11-07

決定日期2017-11-07

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

UltraVision 2 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Winprobe Corporation. It received FDA 510(k) clearance on 2017-11-07 under 510(k) number K173265. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UltraVision 2 Diagnostic Ultrasound System?

UltraVision 2 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-11-07. The listed applicant is Winprobe Corporation. The 510(k) number is K173265.

When did UltraVision 2 Diagnostic Ultrasound System receive FDA 510(k) clearance?

UltraVision 2 Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-11-07, under 510(k) number K173265.

Who is the listed applicant for UltraVision 2 Diagnostic Ultrasound System?

The FDA 510(k) record lists Winprobe Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraVision 2 Diagnostic Ultrasound System?

The FDA product code for UltraVision 2 Diagnostic Ultrasound System is IYN.

相關器械（代碼：IYN）

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。

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：IYN）

官方來源