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Natus 515-005800

by Natus Neurology Incorporated

Natus 515-005800 is a Class II device made by Natus Neurology Incorporated, cleared under FDA 510(k) K061908 on 6 Nov 2006 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00382830037822), 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) K061908

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 Number00382830037822 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK061908 Date6 Nov 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061908 decided 6 Nov 2006 Active
  • FDA GUDID UDI-DI 00382830037822 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061908
  2. Listed FDA GUDID 00382830037822

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  • Withdrawn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
515-005800
Primary DI / UDI-DI
00382830037822
510(k) Number
FDA product code
GWQ
GMDN term
Electroencephalograph
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Electroencephalograph.

Other devices from Natus Neurology Incorporated

See all devices from Natus Neurology Incorporated →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)