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Natus 007134

by Xltek

Natus 007134 is a Class II device made by Xltek, cleared under FDA 510(k) K090019 on 22 Feb 2010 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 00382830041904), active as of 23 Oct 2026. One FDA recall is linked to it.

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) K090019

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 Number00382830041904 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090019 Date22 Feb 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090019 decided 22 Feb 2010 Active
  • FDA GUDID UDI-DI 00382830041904 listed 13 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0661-2022 FDA Class II initiated 2 Dec 2021

    Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user.

Timeline

3 dated events

  1. Cleared FDA 510(k) K090019
  2. Listed FDA GUDID 00382830041904
  3. Recall initiated FDA recalls Z-0661-2022

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  • Withdrawn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
007134
Primary DI / UDI-DI
00382830041904
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 (K090019)

and 8 more cleared under K090019

Similar devices in this category

Other devices filed under Electroencephalograph.

Other devices from Xltek

See all devices from Xltek →

Properties

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