510(k) clearance

QF10

FDA 510(k) source

510(k) number

K261470

Applicant

E.A.M Benelux B.V

Decision date

Sep 9, 2026

Date received

May 4, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NHV

Device type

System, Water Purification, General Medical Use

Device class

Class II

Regulation

21 CFR 876.5665

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Almere, NL