M5 Recorder
Global Instrumentation LLC
GLOBAL INSTRUMENTATION, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005737664 | 3005737664 | GLOBAL INSTRUMENTATION, LLC | 1 | N | 2026-01-01 | 7010 Fly Road STE 5 E Syracuse NY US 13057 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 65365 | 1288645712 | K202456 | M5 Recorder | DSH | 2020-12-29 |
| 65365 | 1285867079 | K162463 | Matrix Data Management System | DXN | 2017-05-24 |
| 65365 | 1041802961 | K152701 | Matrix Mini ECG Monitor | DSI | 2016-04-22 |
| 65365 | 1214043554 | K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | MLO | 2005-09-26 |
Product Codes Associated With Registrations#
PMN#
Matrix Data Management System
GLOBAL INSTRUMENTATION, LLC
Matrix Mini ECG Monitor
GLOBAL INSTRUMENTATION, LLC
MATRIX HOLTER SYSTEM, MODEL M12
GLOBAL INSTRUMENTATION, LLC
GUDID#
M12 System - SD Card (GI Label)
2024-12-03
Matrix Wearable - M5 Recorder, 3-Lead Patient Cable AHA, System Kit00815187020556; M5 Recorder00815187020457; M5 3-Lead Patient Cable AHA00815187020549; M5 USB Cable 1-Meter
2024-04-01
Matrix Wearable - M5 Recorder, 2-Lead Patient Cable AHA, System Kit00815187020556; M5 Recorder00815187020440; M5 2-Lead Patient Cable AHA00815187020549; M5 USB Cable 1-Meter
2024-04-01
Matrix Wearable - M5 3-Lead Patient Cable AHA
2024-04-01
Matrix Wearable - M5 2-Lead Patient Cable AHA
2024-04-01
Matrix Wearable - M5 Patient Cable Cradle
2024-04-01
Matrix Holter System - M12R L Recorder, 10-Lead Cable, AHA, System Kit90815187020184; M12R, 10 Lead patient Cable (DIN)90815187020252; M12R Holter Recorder90815187020320; M12R Carrying Case
2022-04-29
Matrix Holter System - M12R Recorder, 7-Lead Cable AHA, System Kit90815187020153; M12R, 7 Lead patient Cable (AHA)90815187020252; M12R Holter Recorder90815187020320; M12R Carrying Case
2022-04-29
Matrix Holter System - M12R Recorder, 10-Lead Cable AHA, System Kit90815187020191; M12R, 10 Lead Patient Cable90815187020252; M12R Holter Recorder90815187020320; M12R Carrying Case
2022-04-29
Matrix Wearable - M5 Recorder, 4-Lead Patient Cable RL Lead AHA, System Kit00815187020556; M5 Recorder00815187020471; M5 4-Lead Patient Cable - RL Lead AHA00815187020549; M5 USB Cable 1-Meter
2021-03-11
Matrix Wearable - M5 Recorder, USB Cable, USB Wall Charger, System Kit00815187020556; M5 Recorder00815187020549; M5 USB Cable 1-Meter
2021-03-11
Matrix Wearable - M5 USB Cable 1-Meter
2021-03-11
Matrix Wearable - M5 4-Lead Patient Cable - RL Lead AHA
2021-03-11
Matrix Wearable - M5 Neck Lanyard
2021-08-10
Matrix Wearable - M5 Patch Electrode, 2-Lead
2021-03-11
Matrix Wearable - M5 Recorder
2021-03-11
GI Holter System - M3R Intermittent and Continuous ECG Recorder
2018-08-27
Matrix Holter System - M12A Enterprise System Software
2018-03-22
Matrix Holter System - M12A Office System Software
2018-03-22
GI Holter System - M3R Holter Recorder
2017-04-12
Patient Cable - 5 Lead Patient Cable, IEC, M3R
2017-02-02
Battery Cover - HR100 Battery Cover
2016-10-21
Battery Cover - HR300/M3R/M12R Battery Cover
2016-10-21
Pouch - HR300/HR1200/M3R/M12R Carrying Case and Strap
2016-10-21
Pouch - HR100 Carrying Case and Strap
2016-10-21
WA Holter System - HR300 Mini Holter Recorder Repair Exchange
2016-10-21
WA Holter System - HR300 Holter Repair Exchange
2016-10-21
WA Holter System - HR100 Holter Repair Exchange
2016-10-21
GI Holter System - M12R L Holter Recorder
2016-10-21
GI Holter System - M12R Holter Recorder
2016-10-21
GI Holter System - M3R L Holter Recorder
2016-10-21
Patient Cable - 7 Lead Patient Cable, IEC, HR100
2016-10-21
Patient Cable - 7 Lead Patient Cable, AHA, HR100
2016-10-21
Patient Cable - 5-Lead Patient Cable, IEC
2016-10-21
Patient Cable - 5-Lead Patient Cable, AHA, HR100
2016-10-21
Patient Cable - M12R, 10 Lead Patient Cable
2016-10-21
Patient Cable - M12R, 10 Lead patient Cable (DIN)
2016-10-21
Patient Cable - M12R, 10 Lead patient Cable (AHA)
2016-10-21
Patient Cable - M3R/M12R, 7 Lead patient Cable
2016-10-21
Patient Cable - M3R/M12R, 7 Lead patient Cable (AHA)
2016-10-21