FDA Registration
Active
🇺🇸 United States
DICTUM HEALTH, INC.
Reg #: 3011359729
·
FEI: 3011359729
·
Expires 2025
Products
10
Proprietary Names
0
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- DICTUM HEALTH, INC.
- Registration Number
- 3011359729
- FEI Number
- 3011359729
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 32860 Pacific Coast Highway
- City
- Malibu
- State
- CA
- ZIP
- 90265
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170798
Owner / Operator
- Firm Name
- Dictum Health
- Operator Number
- 10051189
- Address
- 32860 Pacific Coast Highway
- City
- Malibu
- State
- CA
- Postal Code
- 90265
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2017-08-22 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2017-08-22 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2017-08-22 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2017-08-22 |
| Audiometer | EWO | Class 2 | Ear, Nose, Throat | No | 2017-08-22 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2017-08-22 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2017-08-22 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2017-08-22 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2017-08-22 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2017-08-22 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198