Skip to content

Medi-Dx 7000 Cpt with Amrex Electrodes

by Neuro-Diagnostic Assoc.

510(k) K980866

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980866 Date20 May 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
GWF
Device Class
Class II
Regulation
21 CFR Part 882.1870
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Neuro-Diagnostic Assoc.

  • Medi-Dx 7000

    Class I