FDA Registration
Active
🇨🇳 China
Acessa ProVe system
Reg #: 3010280625
·
FEI: 3010280625
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ATL Technology DG,Ltd.
- Registration Number
- 3010280625
- FEI Number
- 3010280625
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Xi Xing , XiTou Village, Kang Le Nan Main Road, Houjie Town
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K181124
Owner / Operator
- Firm Name
- ATL Technology LLC
- Operator Number
- 10043021
- Address
- 1335 West 1650 North
- City
- Springville
- State
- UT
- Postal Code
- 84663
- Country
- US
US Agent
- Business Name
- ATL Technology
- Contact Name
- Lauren Cordova
- Address
- 1335 West 1650 North
- City
- Springville
- State
- UT
- ZIP
- 84663
- Country
- US
- [email protected]
- Phone
- 801 8534035 ext. 235
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2019-04-03 |
| Coagulator, Laparoscopic, Unipolar (And Accessories) | HFG | Class 2 | Obstetrics/Gynecology | No | 2019-04-03 |
| Tracking, Soft Tissue, Intraoperative | OEW | Class 2 | Neurology | No | 2019-04-03 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2019-04-03 |
Proprietary Names
Acessa ProVe system
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)