FDA Registration
Active
🇺🇸 United States
S1000, S2000, S3000 & transducers; CW2 CW5 MC9-4 9L-4 14L5 4P1 6C2 4C1 6C1HD 8C3HD 4V1 10V414L5SP 7CF2 7CF1 9EVF4 8V3
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
- K132804
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 Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2018-10-24 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2018-10-24 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2018-10-24 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2018-10-24 |
Proprietary Names
S1000, S2000, S3000 & transducers; CW2 CW5 MC9-4 9L-4 14L5 4P1 6C2 4C1 6C1HD 8C3HD 4V1 10V414L5SP 7CF2 7CF1 9EVF4 8V3
Establishment Types
Repack or Relabel Medical Device