FDA 510(k)

InVision 精密 LVEF (LVEF)

K号: K232331 · 2024-04-25

申请人InVision Medical Technology Corporation

决定日期2024-04-25

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明InVision Medical Technology Corporation为申报人的其他记录

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