FDA Registration
Active
🇺🇸 United States
863379, SureSigns VS4 U.S. Gov NBP. SPO2
Reg #: 1218950
·
FEI: 1218950
·
Expires 2025
Products
7
Proprietary Names
2
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Philips North America LLC
- Registration Number
- 1218950
- FEI Number
- 1218950
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3000 Minuteman Rd
- City
- ANDOVER
- State
- MA
- ZIP
- 01810
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163649
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 |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-10-13 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-10-13 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2022-10-13 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2022-10-13 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2022-10-13 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-10-13 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-10-13 |
Proprietary Names
863379, SureSigns VS4 U.S. Gov NBP. SPO2
863283, SureSigns VS4 Vital Sign Monitor
Establishment Types
Complaint File Establishment per 21 CFR 820.198