FDA Registration
Active
🇺🇸 United States
BM-001B
Reg #: 2080783
·
FEI: 2080783
·
Expires 2025
Products
7
Proprietary Names
27
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- NIHON KOHDEN AMERICA, INC.
- Registration Number
- 2080783
- FEI Number
- 2080783
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 15353 Barranca Pkwy
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K010590
Owner / Operator
- Firm Name
- NIHON KOHDEN CORP.
- Operator Number
- 8030227
- Address
- 1-31-4 NISHIOCHIAI, SHINJUKU-KU
- City
- TOKYO
- State
- JP-13
- Postal Code
- 161-8560
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Galvanic Skin Response Measurement | GZO | Class 2 | Neurology | No | 2007-11-28 |
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2007-11-28 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2007-11-28 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2007-11-28 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2007-11-28 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2007-11-28 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2007-11-28 |
Proprietary Names
BM-001B
BM-701B
MEB-9400A-DT
NE-132B
MEB-9400A
NE-430B
YZ-0172
YZ-004A4
QP-946BK
YE-103J
A/NIH9000
JB-962B
JB-964B
DI-960B
QP-948BK
SC-900B
A/NWB-HL7CS
JB-910B
DR-531B-14
KH-960A
RY-960B
RY-441B
KD-019A
LS-102J
KH-001A
NE-134A
QP-947BK
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device