FDA Registration
Active
🇨🇦 Canada
MIMOSA Pro (previously Imager)
Reg #: 3021337298
·
FEI: 3021337298
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MIMOSA DIAGNOSTICS INC.
- Registration Number
- 3021337298
- FEI Number
- 3021337298
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 434, 366 Adelaide St East
- City
- Toronto Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K190334
Owner / Operator
- Firm Name
- MIMOSA Diagnostics Inc.
- Operator Number
- 10083796
- Address
- Unit 434, 366 Adelaide St East
- City
- Toronto
- State
- Ontario
- Postal Code
- M5A3X9
- Country
- CA
- Correspondent
- General Leung
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2022-01-03 |
Proprietary Names
MIMOSA Pro (previously Imager)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device