510(k) Report

FDA applicant

Cardio Control BV

The Netherlands, NL4 decisions1992–19970 recalls

FDA records 4 decisions for Cardio Control BV (The Netherlands, NL) from 1992 to 1997: 4 510(k) clearances. Most are in product codes LOS (Unnamed device) and 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 Cardio Control BV’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio Control BV since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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