510(k) K250635

Device

FEops HEARTguide Simulation Application

Applicant

Feops NV

510(k) number

K250635

Product code

QQI

Decision

Substantially Equivalent (SESE)

Decision date

2025-11-25

Date received

2025-03-03

Regulation

870.1405

Classification name

Interventional Cardiovascular Implant Simulation Software Device

Medical specialty

Cardiovascular

Review panel

Cardiovascular

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N