FDA Registration
Active
🇺🇸 United States
Sierra Wave EMG/EP
Reg #: 3020018
·
FEI: 3020018
·
Expires 2025
Products
8
Proprietary Names
3
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- CADWELL INDUSTRIES, INC.
- Registration Number
- 3020018
- FEI Number
- 3020018
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 909 N Kellogg St
- City
- KENNEWICK
- State
- WA
- ZIP
- 99336
- Country
- US
Regulatory Submissions
- 510(k) Number
- K971214
Owner / Operator
- Firm Name
- CADWELL INDUSTRIES, INC.
- Operator Number
- 3020018
- Address
- 909 NORTH KELLOGG ST., --
- City
- Kennewick
- State
- WA
- Postal Code
- 99336
- Country
- US
- Correspondent
- Becky Corral
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2007-12-11 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2007-12-11 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2007-12-11 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2007-12-11 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2007-12-11 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2007-12-11 |
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2007-12-11 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2007-12-11 |
Proprietary Names
Sierra Wave EMG/EP
Easy III EEG/PSG
Cascade Pro IOM
Establishment Types
Manufacture Medical Device