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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Water Purification, General Medical Use
510(k) Number K261470
Device Name QF10
Applicant
E.A.M Benelux B.V
Korenbloemweg 79
Almere,  NL 1338XT
Applicant Contact Ilan Aberman
Correspondent
Merona Regulatory Partners
P.O. Box 3037
Biriya,  IL 1380500
Correspondent Contact Chezi Gerin
Regulation Number876.5665
Classification Product Code
NHV  
Date Received05/04/2026
Decision Date 09/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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