Matrix Data Management System

FDA 510(k) K162463 · Global Instrumentation, LLC

Substantially Equivalent

510(k) numberK162463

Submission

Device name
Matrix Data Management System
Applicant
Global Instrumentation, LLC
Manlius, NY, US
Received
September 2, 2016
Decision date
May 24, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXN – System, Measurement, Blood-Pressure, Non-Invasive
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1130
Specialty
Cardiovascular

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Questions and answers

When was Matrix Data Management System cleared by the FDA?

Matrix Data Management System (K162463) received a 510(k) decision of Substantially Equivalent on May 24, 2017, 264 days after the submission was received.

What is the product code of K162463?

The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.