FDA Registration
Active
🇺🇸 United States
SonoSite Edge, C60x/5-2, HFL38x/13-6, L38xi/10-5, HFL50x/15-6, L25X/13-6, P21x/5-1
Reg #: 3012385618
·
FEI: 3012385618
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ADVANCED ULTRASOUND ELECTRONICS
- Registration Number
- 3012385618
- FEI Number
- 3012385618
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9522 E 47th Pl, Suite C
- City
- Tulsa
- State
- OK
- ZIP
- 74145
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113156
Owner / Operator
- Firm Name
- Advanced Ultrasound Electronics
- Operator Number
- 10057460
- Address
- 9522 E 47th Pl, Suite C
- City
- Tulsa
- State
- OK
- Postal Code
- 74145
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2018-04-16 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2018-04-16 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2018-04-16 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-04-16 |
Proprietary Names
SonoSite Edge, C60x/5-2, HFL38x/13-6, L38xi/10-5, HFL50x/15-6, L25X/13-6, P21x/5-1
Establishment Types
Repack or Relabel Medical Device