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Natus 10058

by Xltek

Natus 10058 is a Class II device made by Xltek, cleared under FDA 510(k) K941144 on 7 Nov 1995 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 00382830002264), 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) K941144

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 Number00382830002264 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK941144 Date7 Nov 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K941144 decided 7 Nov 1995 Active
  • FDA GUDID UDI-DI 00382830002264 listed 13 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K941144
  2. Listed FDA GUDID 00382830002264

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  • Withdrawn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
Electromyograph
Model / reference
10058
Primary DI / UDI-DI
00382830002264
510(k) Number
FDA product code
IKN
GMDN term
Electromyograph
Device class
Class II
Regulation number
890.1375
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electromyograph

Cleared under the same submission (K941144)

and 5 more cleared under K941144

Similar devices

Other devices filed under FDA product code IKN (Electromyograph, Diagnostic).

Other devices from Xltek

See all devices from Xltek →

Properties

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