FDA Registration
Active
🇺🇸 United States
Decisio Health Patient Dashboard
Reg #: 3012994996
·
FEI: 3012994996
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DECISIO HEALTH, INC
- Registration Number
- 3012994996
- FEI Number
- 3012994996
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 520 Post Oak Blvd. Suite 600
- City
- Houston
- State
- TX
- ZIP
- 77027
- Country
- US
Regulatory Submissions
- 510(k) Number
- K142106
Owner / Operator
- Firm Name
- Decisio Health, Inc
- Operator Number
- 10052409
- Address
- 520 Post Oak Blvd. Suite 600
- City
- Houston
- State
- TX
- Postal Code
- 77027
- Country
- US
- Correspondent
- Jeff Tomasek
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2016-07-27 |
Proprietary Names
Decisio Health Patient Dashboard
DecisioInsight
InsightIQ
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device