FDA Registration
Active
🇺🇸 United States
Cleerly Coronary; Cleerly Labs v2
Reg #: 3017167291
·
FEI: 3017167291
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CLEERLY, INC
- Registration Number
- 3017167291
- FEI Number
- 3017167291
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1099 18th Street, Suite 2860
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202280
Owner / Operator
- Firm Name
- Cleerly, Inc
- Operator Number
- 10076670
- Address
- 1099 18th street, Suite 2860
- City
- Denver
- State
- CO
- Postal Code
- 80202
- Country
- US
- Correspondent
- James Min
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-12-09 |
Proprietary Names
Cleerly Coronary; Cleerly Labs v2
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198