The following data is part of a premarket notification filed by Global Instrumentation, Llc with the FDA for Matrix Data Management System.
| Device ID | K162463 |
| 510k Number | K162463 |
| Device Name: | Matrix Data Management System |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | GLOBAL INSTRUMENTATION, LLC 8104 CAZENOVIA ROAD Manlius, NY 13104 |
| Contact | Jason Demaso |
| Correspondent | Jason Demaso GLOBAL INSTRUMENTATION, LLC 8104 CAZENOVIA ROAD Manlius, NY 13104 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-02 |
| Decision Date | 2017-05-24 |
| Summary: | summary |