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Ics Chartr Ep 200

by Gn Otometrics A/S

510(k) K083399

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083399 Date20 Feb 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0170-2020 FDA Class II initiated 28 May 2019

    There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.

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  • Withdrawn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
GWJ
Device Class
Class II
Regulation
21 CFR Part 882.1900
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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