FDA Registration
Active
🇮🇳 India
Care Orchestrator
Reg #: 3033526676
·
FEI: 3033526676
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Philips India Limited - Sleep & Respiratory Care Business Unit
- Registration Number
- 3033526676
- FEI Number
- 3033526676
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka
- City
- Bengaluru Karnataka
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K201439
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 2518422
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
US Agent
- Business Name
- Philips
- Contact Name
- Tom Fallon
- Address
- 6501 Living Place
- City
- Pittsburgh
- State
- PA
- ZIP
- 15206
- Country
- US
- [email protected]
- Phone
- 978 9415572
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2024-10-31 |
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2024-10-31 |
| Ventilator, Continuous, Minimal Ventilatory Support, Facility Use | MNT | Class 2 | Anesthesiology | No | 2024-10-31 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2024-10-31 |
| Continuous, Ventilator, Home Use | NOU | Class 2 | Anesthesiology | No | 2024-10-31 |
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | Class 2 | Neurology | No | 2024-10-31 |
| Ventilator, Continuous, Non-Life-Supporting | MNS | Class 2 | Anesthesiology | No | 2024-10-31 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2024-10-31 |
Proprietary Names
Care Orchestrator
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)