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Natus 002978

by Xltek

Natus 002978 is a Class II device made by Xltek, cleared under FDA 510(k) K093304 on 11 Aug 2010 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00382830010955), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K093304

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00382830010955 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK093304 Date11 Aug 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093304 decided 11 Aug 2010 Active
  • FDA GUDID UDI-DI 00382830010955 listed 20 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1067-2015 FDA Class II initiated 2 Jan 2015 on shared 510(k) K093304

    Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K093304
  2. Recall initiated FDA recalls Z-1067-2015
  3. Listed FDA GUDID 00382830010955

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Natus
Generic name
Electromyograph
Model / reference
002978
Primary DI / UDI-DI
00382830010955
510(k) Number
FDA product code
GWF
GMDN term
Electromyograph
Device class
Class II
Regulation number
882.1870
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electromyograph

Cleared under the same submission (K093304)

and 6 more cleared under K093304

Similar devices

Other devices filed under FDA product code GWF (Stimulator, Electrical, Evoked Response).

Other devices from Xltek

See all devices from Xltek →

Properties

  • Supplied sterile
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)