FDA Registration
Active
🇺🇸 United States
Vivo 65
Reg #: 3010817335
·
FEI: 3010817335
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BREAS MEDICAL, INC.
- Registration Number
- 3010817335
- FEI Number
- 3010817335
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 16 Esquire Road
- City
- N Billerica
- State
- MA
- ZIP
- 01862
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160481
Owner / Operator
- Firm Name
- BREAS MEDICAL, INC.
- Operator Number
- 10046641
- Address
- 16 Esquire Road
- City
- N Billerica
- State
- MA
- Postal Code
- 01862
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-06-09 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2022-06-09 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-06-09 |
| Continuous, Ventilator, Home Use | NOU | Class 2 | Anesthesiology | No | 2022-06-09 |
Proprietary Names
Vivo 65
Establishment Types
Complaint File Establishment per 21 CFR 820.198