EXPRESSEYE
FDA 510(k) clearance K992473 · decided 1999-08-12
Clearance details
- K-number
- K992473
- Device name
- EXPRESSEYE
- Applicant
- Optomotor Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1999-07-26
- Decision date
- 1999-08-12
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- GWN
- Device class
- 2
- Regulation number
- 882.1460
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- D-79104 Freiburg, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Optomotor Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SMARTVERTIGO™ Vestibular Assessment System (K260566) | VertigoDx, Inc. | 2026-07-30 |
| NeuroEars-Anna™ (K243709) | Neuroears, Inc. | 2025-08-25 |
| ICS Dizcovery (1091) (K242198) | Natus Medical Denmark Aps | 2025-02-14 |
| Synapsys VHIT (K242726) | Inventis S.R.L. | 2025-01-03 |
| NeuroSwift Pro (K223047) | Neurobit Technologies Co., Ltd. | 2023-06-29 |
| Insight Infrared Video Goggles (K203082) | Vestibular First | 2020-11-12 |
| VisualEyes (K200534) | Interacoustics A/S | 2020-08-12 |
| I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph (K192186) | Neurolign USA, LLC | 2019-11-29 |
| RightEye Vision System (K181771) | Righteye, LLC | 2018-09-28 |
| DizzyDoctor System 1.0.0 (K182214) | Dizzydoctor Systems, LLC | 2018-09-14 |
| I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System (K181025) | Neuro Kinetics, Inc. | 2018-07-24 |
| I-Portal Portable Assessment System - Nystagmograph (I-PAS) (K171884) | Neuro Kinetics, Inc. | 2017-11-22 |
Recalls involving this device
No recalls on record reference this clearance.