FDA Registration
Active
🇺🇸 United States
ETYMOTIC RESEARCH, INC.
Reg #: 1450042
·
FEI: 1450042
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ETYMOTIC RESEARCH, INC.
- Registration Number
- 1450042
- FEI Number
- 1450042
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1125 Remington Road
- City
- Schaumburg
- State
- IL
- ZIP
- 60173
- Country
- US
Regulatory Submissions
- 510(k) Number
- K930003
Owner / Operator
- Firm Name
- ETYMOTIC RESEARCH, INC.
- Operator Number
- 1450042
- Address
- 1125 Remington Rd, --
- City
- Schaumburg
- State
- IL
- Postal Code
- 60173
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-11-02 |
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 2008-11-26 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2020-02-11 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2022-11-02 |
| Cushion, Earphone (For Audiometric Testing) | ETT | Class 1 | Ear, Nose, Throat | No | 1992-06-15 |
Proprietary Names
Enlite
ER-3C Insert Earphones
ER-3A Insert Earphones
Lucid Portable Charging Case
Lucid Rechargeable Battery Module
Renew
Accent
fio
TALA
ER3-14 Eartips, ER38-14 Eartips, ER38-15 Eartips, ER38-18 Eartips
Home Hearing Test
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility