hearOAE
FDA 510(k) clearance K231545 · decided 2023-10-27
Clearance details
- K-number
- K231545
- Device name
- hearOAE
- Applicant
- Hearx SA (Pty) , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-05-30
- Decision date
- 2023-10-27
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- EWO
- Device class
- 2
- Regulation number
- 874.1050
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Pretoria, ZA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OtoNova/OtoNova Pro (K234095) | Otodynamics | 2024-06-21 |
| Otoport Pro (K240430) | Otodynamics, Ltd. | 2024-03-15 |
| Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE (K213345) | Path Medical GmbH | 2022-06-22 |
| Lyra (K191372) | Interacoustics A/S | 2019-07-15 |
| GSI Corti (K180287) | Grason-Stadler, Inc. | 2018-05-11 |
| Sera (K173567) | Interacoustics A/S | 2018-02-14 |
| GSI Novus (K172403) | Grason-Stadler, Inc. | 2017-10-20 |
| Easyscreen (K171506) | Maico Diagnostics GmbH | 2017-08-29 |
| iHearTest (K151025) | Ihear Medical, Inc. | 2015-12-29 |
| ER36 Series OAE Test System (K150491) | Etymotic Research, Inc. | 2015-03-26 |
| NEURO-AUDIO (K141524) | Teleemg, LLC USA | 2015-03-12 |
| 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 (K143395) | Otodynamics, Ltd. | 2015-02-23 |
Recalls involving this device
No recalls on record reference this clearance.