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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K252663
Device Name Inbentus Versatile
Applicant
Iconic Solutions by Murcia, SL
Calle Central, 13, 1c
Murcia,  ES 30100
Applicant Contact Antonio Alarcón Miñarro
Correspondent
RQM+
5000 Centregreen Way
Suite 100
Cary,  NC  27513
Correspondent Contact Dulciana Chan
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/22/2025
Decision Date 04/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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