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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Cardiovascular Implant Simulation Software Device
510(k) Number K214066
Device Name FEops HEARTguide
Applicant
Feops NV
Technologiepark 122
Gent-Zwijnaarde,  BE 9052
Applicant Contact Peter Mortier
Correspondent
Orthogrow NV
Davincilaan 1
Zaventem,  BE 1930
Correspondent Contact Niels Festjens
Regulation Number870.1405
Classification Product Code
QQI  
Date Received12/27/2021
Decision Date 02/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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