Skip to content

Dg Portable System

by Medelec, Ltd.

510(k) K954157

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 NumberK954157 Date17 Jan 1996ClearedStatusActive

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  • Withdrawn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
OLT
FDA applicant
Medelec , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Medelec, Ltd.

  • Arc

    Class II

  • Sapphire Premiere

    Class II

  • Teca. Millennium

    Class II

  • Dg 3P System

    Class II

  • DG Examiner Plus

    Class II

  • Teca Premiere

    Class II

See all devices from Medelec, Ltd. →