Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)— 510(k) K250078

Name: FDA 510(k) clearance K250078
Creator: U.S. Food and Drug Administration
Published: 2025-05-30

Substantially Equivalent

Mindset Medical, Inc.

FDA 510(k) clearance K250078 for Informed Vital Core Application (IVC App) (v2.0.0.2.0.0), Substantially Equivalent on 2025-05-30. Applicant: Mindset Medical, Inc.. Device class: 2.

Clearance details

Applicant: Mindset Medical, Inc.
Product code: Code QME
Device class: Class 2
Regulation: 21 CFR 870.2785
Advisory panel: Cardiovascular
Date received: 2025-01-13
Decision date: 2025-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

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