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Neuro Diagnostics Model Fcr

by Neurodiagnostics, Inc.

510(k) K830191

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830191 Date18 Feb 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GWK
Device Class
Class II
Regulation
21 CFR Part 882.1845
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Neuro Diagnostics Model Fcr is a Conditioner, Signal, Physiological device classified under Regulation 882.1845. It is intended for use in neurology and is part of the medical specialty of neurological care.

The device is supplied as a single-use item and is not reusable. It is not MRI safe and requires proper storage conditions. The device has received FDA 510(k) clearance under K830191, with a decision date of February 18, 1983.

Other devices from Neurodiagnostics, Inc.