510(k) Report

FDA applicant

Novacor

Rueil Malmaison Cedex, FR2 decisions2004–20050 recalls

FDA records 2 decisions for Novacor (Rueil Malmaison Cedex, FR) from 2004 to 2005: 2 510(k) clearances. All are in product code MLO (Electrocardiograph, Ambulatory, With Analysis…). Its devices cite 7 predicates, 0 of them its own earlier devices. 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 Novacor’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Novacor since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MLOElectrocardiograph, Ambulatory, With Analysis Algorithm2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042108Vista PlusNovacor · 20054cite it

What has FDA decided for it lately?

  • K042108Vista PlusNovacor · 2005
  • K040753R-Test Evolution 3Novacor · 2004

All 2 as Novacor →

Other applicant names beginning “Novacor”

FDA records each applicant name separately; these may or may not be the same firm.

Novacor France 1Novacor Div. 1