FDA Registration
Active
🇺🇸 United States
EnsoSleep
Reg #: 3013724298
·
FEI: 3013724298
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ENSODATA, INC.
- Registration Number
- 3013724298
- FEI Number
- 3013724298
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10 E Doty St. Suite 449
- City
- Madison
- State
- WI
- ZIP
- 53703
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162627
Owner / Operator
- Firm Name
- EnsoData, Inc.
- Operator Number
- 10055296
- Address
- 111 S Hamilton St., Suite 30
- City
- Madison
- State
- WI
- Postal Code
- 53703
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | Class 2 | Neurology | No | 2017-07-03 |
Proprietary Names
EnsoSleep
Establishment Types
Manufacture Medical Device