FEops HEARTguide Simulation Application— 510(k) K250635

Substantially Equivalent

Feops NV

FDA 510(k) clearance K250635 for FEops HEARTguide Simulation Application, Substantially Equivalent on 2025-11-25. Applicant: Feops NV.

Clearance details

Applicant: Feops NV
Product code: Code QQI
Advisory panel: Cardiovascular
Date received: 2025-03-03
Decision date: 2025-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gent, BE

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