FDA Registration
Active
🇺🇸 United States
Fetal Doppler Over The Counter Use
Reg #: 3034284973
·
FEI: 3034284973
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AITRI KWIVA INC
- Registration Number
- 3034284973
- FEI Number
- 3034284973
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 105 S MADISON AVE RICHMOND, KY 40475
- City
- Richmond
- State
- KY
- ZIP
- 40475
- Country
- US
Regulatory Submissions
- 510(k) Number
- K920056
Owner / Operator
- Firm Name
- AITRI KWIVA Inc
- Operator Number
- 10092058
- Address
- 105 S MADISON AVE RICHMOND, KY 40475
- City
- Richmond
- State
- KY
- Postal Code
- 40475
- Country
- US
- Correspondent
- Mengjun Yi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Ultrasonic, Fetal | KNG | Class 2 | Obstetrics/Gynecology | No | 2024-12-31 |
Proprietary Names
Fetal Doppler Over The Counter Use
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)