Skip to content

Natus 012378

by Xltek

Natus 012378 is a Class II device made by Xltek, cleared under FDA 510(k) K042223 on 16 Sep 2004 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 00382830016643), 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) K042223

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 Number00382830016643 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK042223 Date16 Sep 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042223 decided 16 Sep 2004 Active
  • FDA GUDID UDI-DI 00382830016643 listed 13 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042223
  2. Listed FDA GUDID 00382830016643

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  • Withdrawn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
012378
Primary DI / UDI-DI
00382830016643
510(k) Number
FDA product code
OMB
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 (K042223)

and 3 more cleared under K042223

Similar devices in this category

Other devices filed under Electroencephalograph.

Other devices from Xltek

See all devices from Xltek →

Properties

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