FDA Registration
Active
🇺🇸 United States
DIGICARE BIOMEDICAL TECHNOLOGY, INC.
Reg #: 1062836
·
FEI: 3000718682
·
Expires 2026
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- DIGICARE BIOMEDICAL TECHNOLOGY, INC.
- Registration Number
- 1062836
- FEI Number
- 3000718682
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 107 COMMERCE RD.
- City
- BOYNTON BEACH
- State
- FL
- ZIP
- 33426
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183687
Owner / Operator
- Firm Name
- DIGICARE BIOMEDICAL TECHNOLOGY, INC.
- Operator Number
- 9029705
- Address
- 107 COMMERCE RD., --
- City
- BOYNTON BEACH
- State
- FL
- Postal Code
- 33426
- Country
- US
- Correspondent
- ADRIANA - MIRANDA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-09-26 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2019-09-26 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-09-26 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2019-09-26 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2019-09-26 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2019-09-26 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2019-09-26 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2019-09-26 |
Proprietary Names
LifeWindow LW8 Lite Multi-Parameter Monitor
Establishment Types
Manufacture Medical Device