FDA Registration
Active
🇺🇸 United States
Monovo Checkme O2 Max Pulse Oximeter
Reg #: 3021131596
·
FEI: 3021131596
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MONOVO, LLC
- Registration Number
- 3021131596
- FEI Number
- 3021131596
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2578 West 600 North, Suite 201
- City
- Lindon
- State
- UT
- ZIP
- 84042
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191088
Owner / Operator
- Firm Name
- Monovo, LLC
- Operator Number
- 10083664
- Address
- 2578 West 600 North, Suite 201
- City
- Lindon
- State
- UT
- Postal Code
- 84042
- Country
- US
- Correspondent
- Jonathan Munoz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-12-09 |
Proprietary Names
Monovo Checkme O2 Max Pulse Oximeter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility