FDA Registration
Active
🇸🇬 Singapore
186-0137 BIS Sensor Simulator
Reg #: 3008202779
·
FEI: 3008202779
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- CELESTICA ELECTRONICS (S) PTE LTD.
- Registration Number
- 3008202779
- FEI Number
- 3008202779
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6 Serangoon North Avenue 5, #05-03/04, #05-06/07/08
- City
- Singapore Central Singapore
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K062613
Owner / Operator
- Firm Name
- Celestica Electronics (S) Pte Ltd.
- Operator Number
- 10037016
- Address
- 6 Serangoon North Avenue 5 #06-11
- City
- Singapore
- State
- Central Singapore
- Postal Code
- 554910
- Country
- SG
- Correspondent
- Chee Keong Yee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2015-04-14 |
| Index-Generating Electroencephalograph Software | OLW | Class 2 | Neurology | No | 2015-04-14 |
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2015-04-14 |
Proprietary Names
186-0137 BIS Sensor Simulator
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)