510(k) Report

FDA applicant

Oxford Biosignals Limited

Crofton, MD4 decisions2000–20060 recalls

FDA records 4 decisions for Oxford Biosignals Limited (Crofton, MD) from 2000 to 2006: 4 510(k) clearances. Most are in product codes OMC (Reduced- Montage Standard Electroencephalograph) and OLZ (Automatic Event Detection Software For…). Its devices cite 3 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, neurology panel, where it files most

How often FDA has decided Oxford Biosignals Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oxford Biosignals Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Oxford”

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