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FDA 510(k)

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

K-Number: K250078 · 2025-05-30

ApplicantMindset Medical, Inc.
Decision Date2025-05-30
Product CodeQME
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) is a medical device manufactured by Mindset Medical, Inc.. It received FDA 510(k) clearance on 2025-05-30 under approval number K250078. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)?

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) is a medical device that received FDA 510(k) clearance on 2025-05-30. It is manufactured by Mindset Medical, Inc.. The 510(k) number is K250078.

When was Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) approved by the FDA?

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) received FDA 510(k) clearance on 2025-05-30, under approval number K250078.

What company makes Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)?

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) is manufactured by Mindset Medical, Inc..

What is the FDA product code for Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)?

The FDA product code for Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) is QME.

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Other Devices by Mindset Medical, Inc.

K241633Informed Vital Core Application (IVC App)

Related Devices (Code: QME)

K211906Vital SignsOxehealth Limited DEN200019Oxehealth Vital SignsOxehealth Limited K220899Oxehealth Vital SignsOxehealth Limited K223622FaceHeart Vitals Software Development Kit (FH vitals SDK)Faceheart Corp. K240890PanopticAI Vital SignsPanopticAI technologies Limited K241633Informed Vital Core Application (IVC App)Mindset Medical, Inc.

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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