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Ddat Omt

by Ddat(Uk), Ltd. 510(k)

Active United States

510(k) K050098

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050098 Date23 May 2005ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GWN
Device Class
Class II
Regulation
21 CFR Part 882.1460
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent