FDA Registration
Active
🇺🇸 United States
EPIQ Series Diagnostic Ultrasound Systems
Reg #: 2518586
·
FEI: 2518586
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Philips Ultrasound LLC
- Registration Number
- 2518586
- FEI Number
- 2518586
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Echo Dr
- City
- Reedsville
- State
- PA
- ZIP
- 17084
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202216
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2020-09-04 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2020-09-04 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2020-09-04 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-09-04 |
Proprietary Names
EPIQ Series Diagnostic Ultrasound Systems
Establishment Types
Manufacture Medical Device