FDA Registration
Active
🇺🇸 United States
BIS Module
Reg #: 3012528160
·
FEI: 3012528160
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Philips North America LLC
- Registration Number
- 3012528160
- FEI Number
- 3012528160
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1001 Murry Ridge Lane, STE A
- City
- Murrysville
- State
- PA
- ZIP
- 15668
- Country
- US
Regulatory Submissions
- 510(k) Number
- K003038
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 |
|---|---|---|---|---|---|
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2009-10-29 |
| Index-Generating Electroencephalograph Software | OLW | Class 2 | Neurology | No | 2009-10-29 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2009-10-29 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2009-10-29 |
Proprietary Names
BIS Module
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)