FDA 510(k)

Ventripoint醫療系統加強版（VMS+）

K 號：K173810 · 2018-05-14

決定日期2018-05-14

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Ventripoint Medical System Plus (VMS+) is the device name listed in this FDA 510(k) record. The listed applicant is Ventripoint Diagnostics , Ltd.. It received FDA 510(k) clearance on 2018-05-14 under 510(k) number K173810. 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 Ventripoint Medical System Plus (VMS+)?

Ventripoint Medical System Plus (VMS+) is a medical device that received FDA 510(k) clearance on 2018-05-14. The listed applicant is Ventripoint Diagnostics , Ltd.. The 510(k) number is K173810.

When did Ventripoint Medical System Plus (VMS+) receive FDA 510(k) clearance?

Ventripoint Medical System Plus (VMS+) received FDA 510(k) clearance on 2018-05-14, under 510(k) number K173810.

Who is the listed applicant for Ventripoint Medical System Plus (VMS+)?

The FDA 510(k) record lists Ventripoint Diagnostics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ventripoint Medical System Plus (VMS+)?

The FDA product code for Ventripoint Medical System Plus (VMS+) is IYN.

其他以 Ventripoint Diagnostics , 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。

K241222Ventripoint醫療系統 Plus (VMS+) 4.0 K191493Ventripoint醫療系統 Plus (VMS+) 3.0

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

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