FDA Registration
Active
🇺🇸 United States
CommandEP HMD Custom Lens Insert (RXL01)
Reg #: 3017435704
·
FEI: 3017435704
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SENTIAR, INC.
- Registration Number
- 3017435704
- FEI Number
- 3017435704
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 212 N Kingshighway Blvd, Suite 115, Box 28
- City
- Saint Louis
- State
- MO
- ZIP
- 63108
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223290
Owner / Operator
- Firm Name
- SentiAR, Inc.
- Operator Number
- 10077856
- Address
- 212 N Kingshighway Blvd, Suite 115, Box 28
- City
- Saint Louis
- State
- MO
- Postal Code
- 63108
- Country
- US
- Correspondent
- Alex Schreiner
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2023-12-29 |
Proprietary Names
CommandEP HMD Custom Lens Insert (RXL01)
CommandEP Data Manager PC (DPC02)
CommandEP HMD (HMD02)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198