FDA Registration
Active
🇺🇸 United States
Cadwell
Reg #: 2023374
·
FEI: 2023374
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- DIVERSATEK HEALTHCARE INC.
- Registration Number
- 2023374
- FEI Number
- 2023374
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9150 Commerce Center Cir Ste 500
- City
- Highlands Ranch
- State
- CO
- ZIP
- 80129
- Country
- US
Regulatory Submissions
- 510(k) Number
- K971214
Owner / Operator
- Firm Name
- DIVERSATEK HEALTHCARE
- Operator Number
- 2023374
- Address
- 9150 COMMERCE CENTER CIR.,#500, --
- City
- Highlands Ranch
- State
- CO
- Postal Code
- 80129
- Country
- US
- Correspondent
- Laura L Boll
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2017-01-19 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2017-01-19 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2017-01-19 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2017-01-19 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2017-01-19 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2017-01-19 |
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2017-01-19 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2017-01-19 |
Proprietary Names
Cadwell
Establishment Types
Complaint File Establishment per 21 CFR 820.198