510(k) Report

FDA applicant

Cme Telemetrix, Inc.

West Cadwell, NJ1 decision1997–19970 recalls

FDA records 1 decision for Cme Telemetrix, Inc. (West Cadwell, NJ) in 1997: 1 510(k) clearance. All are in product code GYE (Encephalogram Telemetry System). 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, neurology panel, where it files most

How often FDA has decided Cme Telemetrix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cme Telemetrix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cme Telemetrix, 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?

  • GYEEncephalogram Telemetry System1decision

What has FDA decided for it lately?

  • K963195Wireless Eeg Recording System Model W32Cme Telemetrix, Inc. · 1997

The one decision as Cme Telemetrix, Inc. →