PurGuard360(QF10)— 510(k) K261470
Substantially EquivalentE.A.M Benelux B.V
FDA 510(k) clearance K261470 for PurGuard360(QF10), Substantially Equivalent on 2026-09-09. Applicant: E.A.M Benelux B.V. Device class: 2.
Clearance details
- Applicant
- E.A.M Benelux B.V
- Product code
- 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
Recent devices under product code NHV
view all- K222727 — i3 ONE (203100-S); i3 TWO connect (203200-S); i3 TWO direct (203300-S)
- K191563 — FILTRAY 2G Disposable Water Filters
- K182164 — Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
- K173164 — Ecolab POU Water Filter
- K163609 — Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)
Data sourced from openFDA. This site is unofficial and independent of the FDA.