FDA applicant
Cardio Control BV
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
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.
Planning a device like Cardio Control BV’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report