FDA Registration
Active
🇳🇱 Netherlands
GE 0.7T SMALL OPENSPEED GENERAL PURPOSE COIL,
Reg #: 3003768277
·
FEI: 3002807880
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Registration Number
- 3003768277
- FEI Number
- 3002807880
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VEENPLUIS 6
- City
- BEST Noord-Brabant
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K020850
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
- Maria Heiling
- Address
- 3721 Valley Centre Dr. Ste. 500
- City
- San Diego
- State
- CA
- ZIP
- 92130
- Country
- US
- [email protected]
- Phone
- 858 2487651
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2009-05-18 |
Proprietary Names
GE 0.7T SMALL OPENSPEED GENERAL PURPOSE COIL,
GE 0.7T MEDIUM OPENSPEED GENERAL PURPOSE COIL,
GE 0.7T LARGE OPENSPEED GENERAL PURPOSE COIL,
Establishment Types
Complaint File Establishment per 21 CFR 820.198