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Keypoint 9033S0591

by Natus Manufacturing Limited

Keypoint 9033S0591 is a Class II device made by Natus Manufacturing Limited, cleared under FDA 510(k) K944547 on 19 Sep 1995 and listed in FDA GUDID since 26 Mar 2019 (UDI-DI 00382830051064), 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) K944547

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 Number00382830051064 UDI-DI Date26 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK944547 Date19 Sep 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K944547 decided 19 Sep 1995 Active
  • FDA GUDID UDI-DI 00382830051064 listed 26 Mar 2019 Listed

Recalls

1 recall · FDA

    • Terminated Z-1407-2013 FDA Class II initiated 9 Apr 2013

    Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.

Timeline

3 dated events

  1. Cleared FDA 510(k) K944547
  2. Recall initiated FDA recalls Z-1407-2013
  3. Listed FDA GUDID 00382830051064

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Keypoint
Generic name
Electromyograph
Model / Ref / Catalog
9033S0591
Primary DI / UDI-DI
00382830051064
510(k) Number
FDA product code
GWF
GMDN term
Electromyograph
Device class
Class II
Regulation number
882.1870
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electromyograph

Cleared under the same submission (K944547)

and 2 more cleared under K944547

Similar devices

Other devices filed under FDA product code GWF (Stimulator, Electrical, Evoked Response).

Other devices from Natus Manufacturing Limited

See all devices from Natus Manufacturing Limited →

Properties

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