510(k) Report

FDA applicant

Neuro-Diagnostic Assoc.

Laguna Beach, CA2 decisions1997–19980 recalls

FDA records 2 decisions for Neuro-Diagnostic Assoc. (Laguna Beach, CA) from 1997 to 1998: 2 510(k) clearances. Most are in product codes GWF (Stimulator, Electrical, Evoked Response) and LLN (Device, Vibration Threshold Measurement). Its devices cite 2 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 Neuro-Diagnostic Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neuro-Diagnostic Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neuro-Diagnostic Assoc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Neuro-Diagnostic”

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