FDA Registration
Active
🇺🇸 United States
Lifelines Neuro Company
Reg #: 3015491430
·
FEI: 3015491430
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Lifelines Neuro Company
- Registration Number
- 3015491430
- FEI Number
- 3015491430
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 900 East Main Street, STE 300
- City
- Louisville
- State
- KY
- ZIP
- 40206
- Country
- US
Regulatory Submissions
- 510(k) Number
- K010460
Owner / Operator
- Firm Name
- LIFELINES LTD.
- Operator Number
- 9044781
- Address
- 1 TANNERY HOUSE, TANNERY LANE
- City
- WOKING
- State
- Surrey
- Postal Code
- GU23 7EF
- Country
- GB
- Correspondent
- Chloe A Mayo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2001-08-21 |
| Standard Polysomnograph With Electroencephalograph | OLV | Class 2 | Neurology | No | 2001-08-21 |
| Amplifier, Physiological Signal | GWL | Class 2 | Neurology | No | 2018-05-10 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2011-05-24 |
Proprietary Names
Trackit MK3
TRACK IT
Trackit T4 EEG Amplifier
Trackit T4A EEG Amplifier
Lifelines Photic Stimulator
Photic
R-40 EEG Amplifier
Establishment Types
Complaint File Establishment per 21 CFR 820.198