Skip to content

OAE Probe OP23 M032200

by Intelligent Hearing Systems Corp.

OAE Probe OP23 M032200 is a Class II device made by Intelligent Hearing Systems Corp., cleared under FDA 510(k) K023859 on 8 Jan 2003 (1 earlier submission) and listed in FDA GUDID since 10 Jun 2026 (UDI-DI 00817020021133), 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 Number00817020021133 UDI-DI Date10 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK023859 Date8 Jan 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K023859 decided 8 Jan 2003 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00817020021133 listed 10 Jun 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K964426
  2. Cleared FDA 510(k) K023859
  3. Listed FDA GUDID 00817020021133

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
OAE Probe OP23
Generic name
Otoacoustic emission system, line-powered
Model / reference
M032200
Primary DI / UDI-DI
00817020021133
510(k) Number
FDA product code
EWO
GMDN term
Otoacoustic emission system, line-powered
Device class
Class II
Regulation number
874.1050
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K023859)

and 1 more cleared under K023859

Cleared under the same submission (K964426)

and 1 more cleared under K964426

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)