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Screener Cart M998920S

by Intelligent Hearing Systems Corp.

Screener Cart M998920S is a Class II device made by Intelligent Hearing Systems Corp., cleared under FDA 510(k) K090579 on 7 Jul 2009 and listed in FDA GUDID since 10 Jun 2026 (UDI-DI 00817020020723), active as of 22 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 22 Oct 2026

Documents

510(k) K090579

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817020020723 UDI-DI Date10 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090579 Date7 Jul 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090579 decided 7 Jul 2009 Active
  • FDA GUDID UDI-DI 00817020020723 listed 10 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090579
  2. Listed FDA GUDID 00817020020723

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Screener Cart
Generic name
Evoked-potential graphic recording system
Model / reference
M998920S
Primary DI / UDI-DI
00817020020723
510(k) Number
FDA product code
EWO, GWJ
GMDN term
Evoked-potential graphic recording system
Device class
Class II
Regulation number
874.1050, 882.1900
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K090579)

and 5 more cleared under K090579

Other devices from Intelligent Hearing Systems Corp.

See all devices from Intelligent Hearing Systems Corp. →

Properties

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