FDA Registration
Active
🇨🇦 Canada
ResolutionMD
Reg #: 3006123366
·
FEI: 3006123366
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ResolutionMD, Inc.
- Registration Number
- 3006123366
- FEI Number
- 3006123366
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Suite 314, 1212 31 Avenue NE
- City
- CALGARY Alberta
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K161130
Owner / Operator
- Firm Name
- ResolutionMD, Inc.
- Operator Number
- 9090399
- Address
- Suite 314, 1212 31 Avenue NE, --
- City
- CALGARY
- State
- Alberta
- Postal Code
- T2E 7S8
- Country
- CA
- Correspondent
- Sharon - Cholowsky
US Agent
- Business Name
- MDSS USA LLC
- Contact Name
- Marissa Vilchez
- Address
- 6118 W. Lawrence Avenue
- City
- Chicago
- State
- IL
- ZIP
- 60630
- Country
- US
- [email protected]
- Phone
- 312 9751694
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2016-12-09 |
Proprietary Names
ResolutionMD
Synapse Mobility
Establishment Types
Manufacture Medical Device