FDA Registration
Active
🇬🇧 United Kingdom
PATIENT SPIROMETRY SET
Reg #: 3030446844
·
FEI: 3030446844
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- PLATINUM FOCUS GROUP LTD.
- Registration Number
- 3030446844
- FEI Number
- 3030446844
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 5, 1000 North Circular Road
- City
- London London, City of
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K183394
Owner / Operator
- Firm Name
- Platinum Focus Group Ltd.
- Operator Number
- 10089900
- Address
- Unit 5, 1000 North Circular Road
- City
- London
- State
- London, City of
- Postal Code
- NW2 7JP
- Country
- GB
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2024-07-17 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2024-07-17 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2024-07-17 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2024-07-17 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2024-07-17 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | Class 2 | Anesthesiology | No | 2024-07-17 |
| Computer, Oxygen-Uptake | BZL | Class 2 | Anesthesiology | No | 2024-07-17 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2024-07-17 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2024-07-17 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2024-07-17 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2024-07-17 |
Proprietary Names
PATIENT SPIROMETRY SET
Establishment Types
Manufacture Medical Device