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Televix

by General Electrical Espanola, S.A.

510(k) K790692

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790692 Date23 Apr 1979ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1753-2019 FDA Class II initiated 29 Mar 2019

    There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

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  • Withdrawn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
KXJ
Device Class
Class II
Regulation
21 CFR Part 892.1980
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent