FDA Registration
Active
🇺🇸 United States
Capsule Vitals Plus Patient Monitoring System
Reg #: 3006648320
·
FEI: 3006648320
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Philips North America LLC
- Registration Number
- 3006648320
- FEI Number
- 3006648320
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 222 Jacobs Street
- City
- Cambridge
- State
- MA
- ZIP
- 02141
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210204
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 |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-11-07 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-11-07 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-11-07 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2022-11-07 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-11-07 |
Proprietary Names
Capsule Vitals Plus Patient Monitoring System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device