FDA Registration
Active
🇯🇵 Japan
F88 Flexible Camera Control Unit
Reg #: 3000160970
·
FEI: 3000160970
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IKEGAMI TSUSHINKI CO., LTD.
- Registration Number
- 3000160970
- FEI Number
- 3000160970
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 41-2 Hiraide Kogyo Danchi
- City
- Utsunomiya Tochigi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K243894
Owner / Operator
- Firm Name
- Ikegami tsushinki Co., Ltd.
- Operator Number
- 10055510
- Address
- 41-2 Hiraide Kogyo Danchi
- City
- Utsunomiya
- State
- Tochigi
- Postal Code
- 321-0905
- Country
- JP
- Correspondent
- nobuyuki nakajima
US Agent
- Business Name
- Ikegami Electronics (USA) Inc
- Contact Name
- Kenzo Ishizuka
- Address
- 300 Route17 South
- City
- Mahwah
- State
- NJ
- ZIP
- 07430
- Country
- US
- [email protected]
- Phone
- 201 3689171 ext. 278
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2025-06-04 |
Proprietary Names
F88 Flexible Camera Control Unit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)