FDA Registration
Active
🇳🇱 Netherlands
PHILIPS 1.5T INTERA (BDAS) 6C KNEE ARRAY, Philips dS Knee 8ch 3T, Philips dS Knee 8ch 1.5T
Reg #: 3003768277
·
FEI: 3002807880
·
Expires 2025
Products
1
Proprietary Names
7
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
- K033567
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 | 2009-05-19 |
Proprietary Names
PHILIPS 1.5T INTERA (BDAS) 6C KNEE ARRAY, Philips dS Knee 8ch 3T, Philips dS Knee 8ch 1.5T
Philips 1.5TSENSE Intera High Res Knee Array
Toshiba 1.5T Knee SPEEDER, Philips SENSE Knee Coil 3T 8Ch, Phililps 6-ch SENSE Knee Coil 3T
Sense Knee Coil 1.5T
SENSE Knee Coil 1.5T/8CH
dS Knee Coil 1.5T/8ch
SENSE Knee Coil 3T/8CH
Establishment Types
Complaint File Establishment per 21 CFR 820.198