QF10— 510(k) K261470
Substantially EquivalentE.A.M Benelux B.V
FDA 510(k) clearance K261470 for QF10, Substantially Equivalent on 2026-09-09. Applicant: E.A.M Benelux B.V. Device class: 2.
Summary
E.A.M Benelux B.V filed a device named only "QF10" under product code NHV (System, Water Purification, General Medical Use). The name is a model designation, and the record gives no other description.
Class II, 21 CFR 876.5665. Gastroenterology, Urology is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
The company filed from Almere, Netherlands. The decision came 128 calendar days after FDA received it (May 4 to September 9, 2026).
Clearance details
- Applicant
- E.A.M Benelux B.V
- Product code
- Product code NHV
- Device class
- Class 2
- Regulation
- 21 CFR 876.5665
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Almere, NL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.