FDA Registration
Active
🇺🇸 United States
CARDIOCOMMAND, INC.
Reg #: 1927197
·
FEI: 1927197
·
Expires 2026
Products
4
Proprietary Names
6
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- CARDIOCOMMAND, INC.
- Registration Number
- 1927197
- FEI Number
- 1927197
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4920 WEST CYPRESS STREET, SUITE 110
- City
- TAMPA
- State
- FL
- ZIP
- 33607
- Country
- US
Regulatory Submissions
- 510(k) Number
- K904943
- PMA Number
- P840002
Owner / Operator
- Firm Name
- CARDIOCOMMAND, INC.
- Operator Number
- 1927197
- Address
- 4920 WEST CYPRESS STREET, SUITE 110
- City
- Tampa
- State
- FL
- Postal Code
- 33607
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stethoscope, Esophageal, With Electrical Conductors | BZT | Class 2 | Anesthesiology | No | 2008-03-14 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2010-12-08 |
| System, Esophageal Pacing | LPA | Class 3 | Unknown | No | 2007-12-06 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2009-02-05 |
Proprietary Names
TAPSCOPE
TapCath
TapSystem Model 2A
Octapolar
statMAP NIBP Device
TAPCATH
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)