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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 the device name listed in this FDA 510(k) record. The listed applicant is Mindset Medical, Inc.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) 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. The listed applicant is Mindset Medical, Inc.. The 510(k) number is K250078.

When did Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) receive FDA 510(k) clearance?

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

Who is the listed applicant for Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)?

The FDA 510(k) record lists Mindset Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Mindset Medical, Inc. 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.

K241633Informed Vital Core Application (IVC App)

Related Devices (Code: QME)

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.

K254169SmartSpectra Vital Signs Monitor 1.0Presage Security, Inc. d/b/a Presage Technologies, Inc.K253650Anura Mobile Core SDK (M1)Nuralogix CorporationK260066PanopticAI Vital Signs (1.6.1-22)PanopticAI Technologies LimitedK251200Vital SignsOxehealth LimitedK243687Vital SignsOxehealth LimitedK240890PanopticAI Vital SignsPanopticAI technologies Limited

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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