The following data is part of a premarket notification filed by Global Instrumentation, Llc with the FDA for Matrix Mini Ecg Monitor.
| Device ID | K152701 |
| 510k Number | K152701 |
| Device Name: | Matrix Mini ECG Monitor |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | GLOBAL INSTRUMENTATION, LLC 8104 CAZENOVIA ROAD Manlius, NY 13104 |
| Contact | Craig Sellers |
| Correspondent | Craig Sellers GLOBAL INSTRUMENTATION, LLC 8104 CAZENOVIA ROAD Manlius, NY 13104 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2016-04-22 |
| Summary: | summary |