510(k) Report

FDA applicant

Eko Scann AB

Mchenry, IL2 decisions1982–19830 recalls

FDA records 2 decisions for Eko Scann AB (Mchenry, IL) from 1982 to 1983: 2 510(k) clearances. Most are in product codes DQB (Phlebograph, Impedance) and LKM (Counter, Urine Particle). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Eko Scann AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eko Scann AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eko Scann AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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