FDA Registration
Active
🇺🇸 United States
Carefusion Nicolet EDX (Synergy)
Reg #: 2184161
·
FEI: 1000139867
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Ducommun LaBarge Technologies
- Registration Number
- 2184161
- FEI Number
- 1000139867
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2222 E Pensar Dr
- City
- APPLETON
- State
- WI
- ZIP
- 54911
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120979
Owner / Operator
- Firm Name
- Ducommun LaBarge Technologies
- Operator Number
- 10041355
- Address
- 2222 E. Pensar Dr.
- City
- Appleton
- State
- WI
- Postal Code
- 54911
- Country
- US
- Correspondent
- Kenneth Jones
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2015-03-24 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2015-03-24 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2015-03-24 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2015-03-24 |
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2015-03-24 |
| Stimulator, Mechanical, Evoked Response | GZP | Class 2 | Neurology | No | 2015-03-24 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2015-03-24 |
Proprietary Names
Carefusion Nicolet EDX (Synergy)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)