Skip to content

Universal Smart Box M011110

by Intelligent Hearing Systems Corp.

Universal Smart Box M011110 is a Class II device made by Intelligent Hearing Systems Corp., cleared under FDA 510(k) K070608 on 18 Jul 2007 (4 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00817020020051), 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

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817020020051 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK070608 Date18 Jul 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070608 decided 18 Jul 2007 Active· +4 more in the status table
  • FDA GUDID UDI-DI 00817020020051 listed 24 Sep 2016 Listed

Timeline

6 dated events

  1. Cleared FDA 510(k) K900096
  2. Cleared FDA 510(k) K964426
  3. Cleared FDA 510(k) K023859
  4. Cleared FDA 510(k) K031051
  5. Cleared FDA 510(k) K070608
  6. Listed FDA GUDID 00817020020051

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Universal Smart Box
Generic name
Visual-reinforcement audiometer
Model / reference
M011110
Primary DI / UDI-DI
00817020020051
510(k) Number
FDA product code
EWO, GWF, GWE, GWJ
GMDN term
Visual-reinforcement audiometer
Device class
Class II
Regulation number
874.1050, 882.1870, 882.1890, 882.1900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Evoked-potential graphic recording systemOtoacoustic emission system, line-poweredVisual-reinforcement audiometer

Cleared under the same submission (K023859)

and 1 more cleared under K023859

Cleared under the same submission (K031051)

Similar devices

Other devices filed under FDA product code EWO (Audiometer).

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)