FDA Registration
Active
🇺🇸 United States
SRT-100 Vision
Reg #: 3008513398
·
FEI: 3008513398
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SENSUS HEALTHCARE
- Registration Number
- 3008513398
- FEI Number
- 3008513398
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 851 Broken Sound Pkwy. NW#215
- City
- Boca Raton
- State
- FL
- ZIP
- 33487
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150037
Owner / Operator
- Firm Name
- Sensus Healthcare
- Operator Number
- 10033258
- Address
- 851 Broken Sound Pkwy. NW#215
- City
- Boca Raton
- State
- FL
- Postal Code
- 33487
- Country
- US
- Correspondent
- Raul Z Gonzales
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Therapeutic, X-Ray | JAD | Class 2 | Radiology | No | 2016-12-16 |
Proprietary Names
SRT-100 Vision
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198