FDA Registration
Active
🇺🇸 United States
ANNE One
Reg #: 3015529350
·
FEI: 3015529350
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SIBEL HEALTH INC.
- Registration Number
- 3015529350
- FEI Number
- 3015529350
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2017 N Mendell Street, Suite 2SE
- City
- Chicago
- State
- IL
- ZIP
- 60614
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223711
Owner / Operator
- Firm Name
- Sibel Inc.
- Operator Number
- 10060887
- Address
- 2017 N Mendell Street, Suite 2SE
- City
- Chicago
- State
- IL
- Postal Code
- 60614
- Country
- US
- Correspondent
- Kevin Dwyer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2023-08-14 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2023-08-14 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2023-08-14 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2023-08-14 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2023-08-14 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2023-08-14 |
Proprietary Names
ANNE One
Establishment Types
Manufacture Medical Device