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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Perfusion, Kidney
510(k) Number K211224
Device Name RM4 Control Unit
Applicant
Institut Georges Lopez
Parc Tertiaire Du Bois Dieu, 1 Allee Des Chevreuils
Lissieu,  FR 69380
Applicant Contact Matthieu Prouteau
Correspondent
Institut Georges Lopez
Parc Tertiaire Du Bois Dieu, 1 Allee Des Chevreuils
Lissieu,  FR 69380
Correspondent Contact Matthieu Prouteau
Regulation Number876.5880
Classification Product Code
KDN  
Date Received04/23/2021
Decision Date 10/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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