FDA 510(k)

InVision精準LVEF (LVEF)

K 號：K232331 · 2024-04-25

申請人InVision Medical Technology Corporation

決定日期2024-04-25

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

InVision Precision LVEF (LVEF) is the device name listed in this FDA 510(k) record. The listed applicant is InVision Medical Technology Corporation. It received FDA 510(k) clearance on 2024-04-25 under 510(k) number K232331. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the InVision Precision LVEF (LVEF)?

InVision Precision LVEF (LVEF) is a medical device that received FDA 510(k) clearance on 2024-04-25. The listed applicant is InVision Medical Technology Corporation. The 510(k) number is K232331.

When did InVision Precision LVEF (LVEF) receive FDA 510(k) clearance?

InVision Precision LVEF (LVEF) received FDA 510(k) clearance on 2024-04-25, under 510(k) number K232331.

Who is the listed applicant for InVision Precision LVEF (LVEF)?

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

What is the FDA product code for InVision Precision LVEF (LVEF)?

The FDA product code for InVision Precision LVEF (LVEF) is QIH.

其他以 InVision Medical Technology Corporation 為申請人之記錄

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相關器械（代碼：QIH）

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