FDA Registration
Active
🇺🇸 United States
SmartEP
Reg #: 1052723
·
FEI: 1000113738
·
Expires 2025
Products
4
Proprietary Names
7
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- INTELLIGENT HEARING SYSTEMS CORP.
- Registration Number
- 1052723
- FEI Number
- 1000113738
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6860 Sw 81st St
- City
- MIAMI
- State
- FL
- ZIP
- 33143
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163326
Owner / Operator
- Firm Name
- INTELLIGENT HEARING SYSTEMS
- Operator Number
- 9000078
- Address
- 6860 S.W. 81ST ST., --
- City
- Miami
- State
- FL
- Postal Code
- 33143
- Country
- US
- Correspondent
- EDWARD - MISKIEL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2017-10-05 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2017-10-05 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2017-10-05 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2017-10-05 |
Proprietary Names
SmartEP
SmartEP (VEMP)
SmartEP (Somatosensory Package)
Aria
SmartEP (Visual EP Package)
USB Jr Duet
Universal Smart Box
Establishment Types
Manufacture Medical Device