FDA Registration
Active
🇺🇸 United States
Axia
Reg #: 1000634785
·
FEI: 1000634785
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Soma Tech Int'l
- Registration Number
- 1000634785
- FEI Number
- 1000634785
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 166 Highland Park Drive
- City
- Bloomfield
- State
- CT
- ZIP
- 06002
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192343
Owner / Operator
- Firm Name
- Soma Technology Inc.
- Operator Number
- 10040393
- Address
- 166 Highland Park Dr
- City
- Bloomfield
- State
- CT
- Postal Code
- 06002
- Country
- US
- Correspondent
- Peter Leonidas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-02-04 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2025-02-04 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2025-02-04 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-02-04 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2025-02-04 |
Proprietary Names
Axia
Establishment Types
Repack or Relabel Medical Device