510(k) Report

FDA applicant

Electrophysiology Systems, Inc.

Ann Arbor, MI1 decision1995–19950 recalls

FDA records 1 decision for Electrophysiology Systems, Inc. (Ann Arbor, MI) in 1995: 1 510(k) clearance. All are in product code DQK (Computer, Diagnostic, Programmable). 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 Electrophysiology Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Electrophysiology Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Electrophysiology Systems, 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?

  • DQKComputer, Diagnostic, Programmable1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K935186Electrophysiology Systems, Inc. EP-EasyElectrophysiology Systems, Inc. · 19951cites it

What has FDA decided for it lately?

  • K935186Electrophysiology Systems, Inc. EP-EasyElectrophysiology Systems, Inc. · 1995

The one decision as Electrophysiology Systems, Inc. →