510(k) Report

FDA applicant

Melville Software, Ltd.

Ottawa, Ontario, CA2 decisions1994–19940 recalls

FDA records 2 decisions for Melville Software, Ltd. (Ottawa, Ontario, CA) in 1994: 2 510(k) clearances. Most are in product codes GWL (Amplifier, Physiological Signal) and OLV (Standard Polysomnograph With…). 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 Melville Software, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Melville Software, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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