FDA Registration
Active
🇺🇸 United States
Sense4Baby
Reg #: 3010608577
·
FEI: 3010608577
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Advanced Maternity Innovations
- Registration Number
- 3010608577
- FEI Number
- 3010608577
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 400 N Sam Houston Pwky E, Suite 1000
- City
- Houston
- State
- TX
- ZIP
- 77060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143114
Owner / Operator
- Firm Name
- Advanced Maternity Innovations
- Operator Number
- 10054118
- Address
- 400 N Sam Houston Pwky E, Suite 1000
- City
- Houston
- State
- TX
- Postal Code
- 77060
- Country
- US
- Correspondent
- Nathan Stansfield
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2017-02-13 |
| Home Uterine Activity Monitor | LQK | Class 2 | Obstetrics/Gynecology | No | 2017-02-13 |
| Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) | MOH | Class 2 | Obstetrics/Gynecology | No | 2017-02-13 |
Proprietary Names
Sense4Baby
Establishment Types
Remanufacture Medical Device
Manufacture Medical Device