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FDA 510(k)

InVision Precision LVEF (LVEF)

K-Number: K232331 · 2024-04-25

ApplicantInVision Medical Technology Corporation
Decision Date2024-04-25
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing InVision Medical Technology Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243866InVision Precision Cardiac Amyloid

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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