FDA Registration
Active
🇺🇸 United States
GLOBAL INSTRUMENTATION, LLC
Reg #: 3005737664
·
FEI: 3005737664
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- GLOBAL INSTRUMENTATION, LLC
- Registration Number
- 3005737664
- FEI Number
- 3005737664
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7010 Fly Road STE 5
- City
- E Syracuse
- State
- NY
- ZIP
- 13057
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152701
Owner / Operator
- Firm Name
- GLOBAL INSTRUMENTATION, LLC
- Operator Number
- 9074706
- Address
- 7010 Fly Road STE 5, --
- City
- E Syracuse
- State
- NY
- Postal Code
- 13057
- Country
- US
- Correspondent
- CRAIG - SELLERS
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2016-09-22 |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | Class 2 | Cardiovascular | No | 2006-05-17 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2021-03-01 |
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2021-03-01 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2024-11-26 |
Proprietary Names
MATRIX HOLTER SYSTEM
M5 Recorder
Matrix Data Management System
Establishment Types
Manufacture Medical Device