FDA Registration
Active
🇩🇪 Germany
OCTAVIUS Control Unit
Reg #: 9681124
·
FEI: 3007360740
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PTW FREIBURG
- Registration Number
- 9681124
- FEI Number
- 3007360740
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LOERRACHER STRASSE 7
- City
- FREIBURG Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K160405
Owner / Operator
- Firm Name
- PTW Freiburg
- Operator Number
- 9010117
- Address
- Loerracher Strasse 7
- City
- Freiburg
- State
- Baden-Wurttemberg
- Postal Code
- D-79115
- Country
- DE
US Agent
- Business Name
- PTW NORTH AMERICA CORPORATION
- Contact Name
- Robert Morrison
- Address
- 6 Mars Court Unit 5
- City
- Boonton
- State
- NJ
- ZIP
- 07005
- Country
- US
- [email protected]
- Phone
- 973 4041999
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2018-05-09 |
Proprietary Names
OCTAVIUS Control Unit
VeriSoft
MultiCheck
Inclinometer
Detector Interface
OCTAVIUS detector, multiple
OCTAVIUS I, II, III, 4D
BeamAdjust
OCTAVIUS Rotation Unit
PQA Soft
OCTAVIUS detector MR, multiple
Establishment Types
Manufacture Medical Device