FDA Registration
Active
🇦🇺 Australia
EchoSolv AS
Reg #: 3033588305
·
FEI: 3033588305
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ECHOIQ LIMITED
- Registration Number
- 3033588305
- FEI Number
- 3033588305
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- L 11 66 Clarence Street
- City
- Sydney New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K241245
Owner / Operator
- Firm Name
- EchoIQ Limited
- Operator Number
- 10091564
- Address
- Level 11, 66 Clarence Street
- City
- Sydney
- State
- New South Wales
- Postal Code
- 2000
- Country
- AU
- Correspondent
- Dane Brescacin
US Agent
- Business Name
- Echo IQ Ltd
- Contact Name
- Dustin Haines
- Address
- 12254 W Creosote Dr
- City
- Peoria
- State
- AZ
- ZIP
- 85383
- Country
- US
- [email protected]
- Phone
- 919 6245212
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | Class 2 | Radiology | No | 2024-10-16 |
Proprietary Names
EchoSolv AS
Establishment Types
Manufacture Medical Device