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Nervus Monitor

by Taugagreining HF

510(k) K021185

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK021185 Date12 Jul 2002ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2568-2018 FDA Class II initiated 1 Feb 2018

    Potential to be able to import an ambulatory exam for a patient for which the exam was not started.

    • Terminated Z-0126-2008 FDA Unclassified (pre-2012) initiated 11 Sep 2007 on shared 510(k) K021185

    Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
OLV
Device Class
Class II
Regulation
21 CFR Part 882.1400
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent