FDA Registration
Active
🇵🇱 Poland
TCM TOSCA Monitoring System
Reg #: 3007490412
·
FEI: 3007490412
·
Expires 2025
Products
5
Proprietary Names
2
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Radiometer Sp. z o.o
- Registration Number
- 3007490412
- FEI Number
- 3007490412
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ul. Podmiejska 3
- City
- Stargard Zachodniopomorskie
- Country
- PL
Regulatory Submissions
- 510(k) Number
- K093154
Owner / Operator
- Firm Name
- RADIOMETER MEDICAL APS
- Operator Number
- 8020503
- Address
- AAKANDEVEJ 21, --
- City
- BROENSHOEJ
- State
- Hovedstaden
- Postal Code
- 2700
- Country
- DK
- Correspondent
- Hsiao-Qing Chow
US Agent
- Business Name
- Radiometer America Inc
- Contact Name
- Matt Ackerman
- Address
- 250 S Kraemer Blvd
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 657 2861022
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK | Class 2 | Anesthesiology | No | 2016-09-02 |
| Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia | LPP | Class 2 | Anesthesiology | No | 2016-09-02 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2016-09-02 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2016-09-02 |
| Monitor, Carbon-Dioxide, Cutaneous | LKD | Class 2 | Anesthesiology | No | 2016-09-02 |
Proprietary Names
TCM TOSCA Monitoring System
TCM CombiM Monitoring System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)