DeviceClearance

Informed Vital Core Application (IVC App)— 510(k) K241633

Substantially Equivalent

Mindset Medical, Inc.

FDA 510(k) clearance K241633 for Informed Vital Core Application (IVC App), Substantially Equivalent on 2024-11-18. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Phoenix, AZ, US
Download summary PDFView on FDA.gov ↗

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