Smarttroae
by Intelligent Hearing Systems
510(k) K023859
Smarttroae is a medical device (FDA Class II; FDA product code EWO, Audiometer) made by Intelligent Hearing Systems, cleared under FDA 510(k) K023859 on 8 Jan 2003, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023859 | Date8 Jan 2003 | StatusActive |
Official records
- FDA 510(k) database K023859
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EWO
- Device class
- Class II
- Regulation
- 21 CFR Part 874.1050
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K023859
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Aria M011160 | M011160 | 00817020021126 | — | On the market |
| OAE 10D Probe M032103 | M032103 | 00817020020273 | — | On the market |
| OAE 10D Probe M032103G | M032103G | 00817020029993 | — | On the market |
| OAE Probe OP23 M032200 | M032200 | 00817020021133 | — | On the market |
| SmartTrOAE Software M814000 | M814000 | 00817020020860 | — | On the market |
| Universal Smart Box M011110 | M011110 | 00817020020051 | — | On the market |
| USB Jr Duet M010300 | M010300 | 00817020020075 | — | On the market |
Similar devices
Other devices filed under FDA product code EWO (Audiometer).
- Patient Response Button 100343 by PATH medical GmbH
- TIMPANI DOCKING STATION 11508 by INVENTIS SRL
- MICROTEK MEDICAL'S SOUND STIKS by Microbio-Medics, Inc.
- ACOUSTIC APPRAISE CD-3 by Qualitone
- GSI Corti by Grason-Stadler, Inc.
- ENTOMED SCREENING AUDIOMETER, MODEL SA201, SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203, SA204 by Entomed AB
- Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit by Otodynamics
- MIDDLE EAR ANALYZER (IMPED. AUDIOMTR) by Grason-Stadler, Inc.
- PORTAREM-3000, PFS-6000 by Starkey Laboratories Inc.
- ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS by Ics Medical Corp.