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Aria M011160

by Intelligent Hearing Systems Corp.

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 10 Nov 2026

Documents

Trust

Unverified

Source GUDID, synced 10 Nov 2026.

Regulatory status

as of registry sync 10 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817020021126 UDI-DI Date11 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK163326 Date29 Sep 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163326 decided 29 Sep 2017 Active· +7 more in the status table
  • FDA GUDID UDI-DI 00817020021126 listed 11 Mar 2024 Listed

Timeline

9 dated events

  1. Cleared FDA 510(k) K900096
  2. Cleared FDA 510(k) K904926
  3. Cleared FDA 510(k) K964426
  4. Cleared FDA 510(k) K023859
  5. Cleared FDA 510(k) K031051
  6. Cleared FDA 510(k) K061443
  7. Cleared FDA 510(k) K090579
  8. Cleared FDA 510(k) K163326
  9. Listed FDA GUDID 00817020021126

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aria
Generic name
Evoked-potential graphic recording system
Model / reference
M011160
Primary DI / UDI-DI
00817020021126
510(k) Number
FDA product code
GWJ, EWO
GMDN term
Evoked-potential graphic recording system
Device class
Class II
Regulation number
882.1900, 874.1050
GUDID distribution status
In Commercial Distribution

Overview

AI-generated summary, 10 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Aria M011160 is an evoked-potential graphic recording system, an otoacoustic emission system, and a visual-reinforcement audiometer. The FDA lists it under the product name Stimulator, Auditory, Evoked Response. This device is an Rx product.

The device received 510(k) clearances K023859, K031051, K061443, K090579, K163326, K900096, K904926, and K964426. It is a Class II device under product codes GWJ and EWO, which correspond to regulation numbers 882.1900 and 874.1050. The labeling for this device does not contain MRI safety information.

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 GWJ (Stimulator, Auditory, Evoked Response).

Other devices from Intelligent Hearing Systems Corp.

See all devices from Intelligent Hearing Systems Corp. →

Questions

AI-generated answers, 10 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Aria M011160?

    It is recorded under the GMDN device type "Evoked-potential graphic recording system", which GMDN defines as "An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs ...". FDA lists it under the product name "Stimulator, Auditory, Evoked Response". It is recorded as Class II.

  • What are the product code and regulation of the Aria M011160?

    FDA records the Aria M011160 under product code GWJ and regulation number 882.1900.

  • Who makes the Aria M011160?

    Intelligent Hearing Systems Corp. is the manufacturer on record for the Aria M011160.

Properties

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