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Natus 10384

by Xltek

Natus 10384 is a Class II device made by Xltek, cleared under FDA 510(k) K040360 on 12 Mar 2004 and listed in FDA GUDID since 6 Jul 2021 (UDI-DI 00382830011235), 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 found

in data synced 23 Oct 2026

Documents

510(k) K040360

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 Number00382830011235 UDI-DI Date6 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK040360 Date12 Mar 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040360 decided 12 Mar 2004 Active
  • FDA GUDID UDI-DI 00382830011235 listed 6 Jul 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040360
  2. Listed FDA GUDID 00382830011235

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  • Withdrawn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
Electroencephalograph
Model / reference
10384
Primary DI / UDI-DI
00382830011235
510(k) Number
FDA product code
GWQ
GMDN term
Electroencephalograph
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electroencephalograph

Cleared under the same submission (K040360)

and 2 more cleared under K040360

Similar devices in this category

Other devices filed under Electroencephalograph.

Other devices from Xltek

See all devices from Xltek →

Properties

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