FDA Registration
Active
🇰🇷 South Korea
IMEDISYNC INC.
Reg #: 3023707151
·
FEI: 3023707151
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- IMEDISYNC INC.
- Registration Number
- 3023707151
- FEI Number
- 3023707151
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5th Floor, 520 Teheran-ro
- City
- Gangnam-gu Seoul
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K222838
Owner / Operator
- Firm Name
- iMediSync Inc.
- Operator Number
- 10085850
- Address
- 15th Floor, 411 Teheran-ro
- City
- Gangnam-gu
- State
- Seoul
- Postal Code
- 06160
- Country
- KR
US Agent
- Business Name
- Kody
- Contact Name
- Newman William Kody
- Address
- 19 Endless Vis
- City
- Aliso Viejo
- State
- CA
- ZIP
- 92656
- Country
- US
- [email protected]
- Phone
- 480 2290054
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Normalizing Quantitative Electroencephalograph Software | OLU | Class 2 | Neurology | No | 2023-03-28 |
| Source Localization Software For Electroencephalograph Or Magnetoencephalograph | OLX | Class 2 | Neurology | No | 2023-03-28 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-08-22 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2022-08-22 |
Proprietary Names
iSyncBrain-C
iSyncWave
Establishment Types
Manufacture Medical Device