FDA Registration
Active
🇺🇸 United States
Tenacore Transducers For Fetal Ultrasonic And Tokodynamometer Monitoring
Reg #: 3008403701
·
FEI: 3008403701
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TENACORE LLC
- Registration Number
- 3008403701
- FEI Number
- 3008403701
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3115 Airway Ave
- City
- Costa Mesa
- State
- CA
- ZIP
- 92626
- Country
- US
Regulatory Submissions
- 510(k) Number
- K043075
Owner / Operator
- Firm Name
- Tenacore LLC
- Operator Number
- 10080555
- Address
- 3115 Airway Ave
- City
- Costa Mesa
- State
- CA
- Postal Code
- 92626
- Country
- US
- Correspondent
- Jason Craner
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2021-02-09 |
Proprietary Names
Tenacore Transducers For Fetal Ultrasonic And Tokodynamometer Monitoring
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility