FDA Registration
Active
🇺🇸 United States
WVSM Pro (Series) (500-0030-XX)
Reg #: 3007413079
·
FEI: 3007413079
·
Expires 2025
Products
9
Proprietary Names
1
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- ATHENA GTX
- Registration Number
- 3007413079
- FEI Number
- 3007413079
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5900 NW 86th St Ste 300
- City
- Johnston
- State
- IA
- ZIP
- 50131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233354
Owner / Operator
- Firm Name
- Athena GTX
- Operator Number
- 10034326
- Address
- 5900 NW 86th Street, Suite 300
- City
- Johnston
- State
- IA
- Postal Code
- 50131
- Country
- US
- Correspondent
- Sean J Mahoney
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2025-02-12 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-02-12 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2025-02-12 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2025-02-12 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2025-02-12 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2025-02-12 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2025-02-12 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2025-02-12 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2025-02-12 |
Proprietary Names
WVSM Pro (Series) (500-0030-XX)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Remanufacture Medical Device
Manufacture Medical Device