510(k) Report

FDA applicant

Cardiac Evaluation Center, Inc.

Milwaukee, WI2 decisions1983–19960 recalls

FDA records 2 decisions for Cardiac Evaluation Center, Inc. (Milwaukee, WI) from 1983 to 1996: 2 510(k) clearances. All are in product code DXH (Transmitters And Receivers…). Its devices cite 1 predicate, 1 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 Cardiac Evaluation Center, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiac Evaluation Center, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardiac Evaluation Center, Inc. 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?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K831406Restrospective Ecg Memory ModuleCardiac Evaluation Center, Inc. · 19831cites it

What has FDA decided for it lately?

  • K954163Retrospective II-Elite Ecg Memory Loop RecorderCardiac Evaluation Center, Inc. · 1996
  • K831406Restrospective Ecg Memory ModuleCardiac Evaluation Center, Inc. · 1983

All 2 as Cardiac Evaluation Center, Inc. →