Data / Medical devices / United States / Global Instrumentation, LLC
Global Instrumentation, LLC: FDA-registered device maker in E Syracuse, NY, United States, 4 510(k) clearances
Global Instrumentation, LLC is registered with the FDA (registration 3005737664) in E Syracuse, NY, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 29, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005737664
- Address
- 7010 Fly Road STE 5, E Syracuse, NY, United States, 13057
- Owner or operator
- GLOBAL INSTRUMENTATION, LLC (9074706)
- Roles
- Manufacturer
- First device listed
- May 17, 2006
- Registered through
- 2026
- Brand names listed
- M5 Recorder, MATRIX HOLTER SYSTEM, Matrix Data Management System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Manufacturer | accessdata.fda.gov |
| Recorder, Magnetic Tape, Medical | DSH | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 29, 2020 | K202456 | M5 Recorder | DSH | Substantially Equivalent | Global Instrumentation, LLC | accessdata.fda.gov |
| May 24, 2017 | K162463 | Matrix Data Management System | DXN | Substantially Equivalent | Global Instrumentation, LLC | accessdata.fda.gov |
| April 22, 2016 | K152701 | Matrix Mini ECG Monitor | DSI | Substantially Equivalent | Global Instrumentation, LLC | accessdata.fda.gov |
| September 26, 2005 | K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | MLO | Substantially Equivalent | Global Instrumentation, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
- All makers of Detector And Alarm, Arrhythmia
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Recorder, Magnetic Tape, Medical
Updated December 29, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.