FDA Registration
Active
🇨🇦 Canada
3T 16Ch GE Shoulder Coil
Reg #: 3000126629
·
FEI: 3000126629
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Philips Electronics Ltd
- Registration Number
- 3000126629
- FEI Number
- 3000126629
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1875 Buckhorn Gate, 5th Floor
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K162001
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
US Agent
- Business Name
- Philips
- Contact Name
- Shaylee Masilunas
- Address
- 6501 Living Place
- City
- Pittsburgh
- State
- PA
- ZIP
- 15206
- Country
- US
- [email protected]
- Phone
- 724 8162019
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2016-09-19 |
Proprietary Names
3T 16Ch GE Shoulder Coil
1.5T 16Ch GE Shoulder Coil
dS 3T 16CH SHOULDER, COIL
dS 1.5T 16CH SHOULDER, COIL
16Ch Shoulder Coil
dS Shoulder 16Ch 3T
dS Shoulder 16Ch 1.5T
Establishment Types
Export Device to the United States But Perform No Other Operation on Device