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Natus 019-415900

by Natus Neurology Incorporated

Natus 019-415900 is a Class II device made by Natus Neurology Incorporated, cleared under FDA 510(k) K850108 on 11 Apr 1985 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00382830040716), 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) K850108

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 Number00382830040716 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK850108 Date11 Apr 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K850108 decided 11 Apr 1985 Active
  • FDA GUDID UDI-DI 00382830040716 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K850108
  2. Listed FDA GUDID 00382830040716

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  • Withdrawn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
Analytical non-scalp cutaneous lead
Model / reference
019-415900
Primary DI / UDI-DI
00382830040716
510(k) Number
FDA product code
GXY
GMDN term
Analytical non-scalp cutaneous lead
Device class
Class II
Regulation number
882.1320
GUDID distribution status
In Commercial Distribution

Related devices

Category: Analytical non-scalp cutaneous lead

Cleared under the same submission (K850108)

and 8 more cleared under K850108

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

Other devices from Natus Neurology Incorporated

See all devices from Natus Neurology Incorporated →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)