FDA 510(k) Application Details - K250078

Device Classification Name	More FDA Info for this Device
510(K) Number	K250078
Device Name	Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
Applicant	Mindset Medical, Inc. 12439 N 32nd St. Phoenix, AZ 85032 US Other 510(k) Applications for this Company
Contact	Jeremy Markovich Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QME Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/2025
Decision Date	05/30/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review