510(k) Report

FDA applicant

Neuroscientific Corp.

Farmingdale, NY2 decisions1988–19881 recall

FDA records 2 decisions for Neuroscientific Corp. (Farmingdale, NY) in 1988: 2 510(k) clearances. Most are in product codes GWL (Amplifier, Physiological Signal) and HOX (Chart, Visual Acuity). 1 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 Neuroscientific Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neuroscientific Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neuroscientific Corp. 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?

  • GWLAmplifier, Physiological Signal1decision
  • HOXChart, Visual Acuity1decision

What has FDA decided for it lately?

  • K880773The Venus SystemNeuroscientific Corp. · 19881 recall
  • K881358PG Consen Contrast Sensitivity Testing ProgramNeuroscientific Corp. · 1988

All 2 as Neuroscientific Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K880773The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing…Sep 15, 2004