510(k) Report

FDA applicant

Ates Medical S.R.L.

Granada Hills, CA1 decision1998–19980 recalls

FDA records 1 decision for Ates Medical S.R.L. (Granada Hills, CA) in 1998: 1 510(k) clearance. All are in product code DPS (Electrocardiograph). 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 Ates Medical S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ates Medical S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ates Medical S.R.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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