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Medi-Stim Veriq System, Model VQ1001 - VQ4122

by Medi-Stim A/S

510(k) K040228

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 NumberK040228 Date29 Apr 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0719-2018 FDA Class II initiated 25 Apr 2017

    A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.

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  • Withdrawn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
DPW
Device Class
Class II
Regulation
21 CFR Part 870.2100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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