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FDA 510(k)

Matrix Data Management System

K-Number: K162463 · 2017-05-24

ApplicantGlobal Instrumentation, LLC
Decision Date2017-05-24
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Matrix Data Management System is a medical device manufactured by Global Instrumentation, LLC. It received FDA 510(k) clearance on 2017-05-24 under approval number K162463. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Matrix Data Management System?

Matrix Data Management System is a medical device that received FDA 510(k) clearance on 2017-05-24. It is manufactured by Global Instrumentation, LLC. The 510(k) number is K162463.

When was Matrix Data Management System approved by the FDA?

Matrix Data Management System received FDA 510(k) clearance on 2017-05-24, under approval number K162463.

What company makes Matrix Data Management System?

Matrix Data Management System is manufactured by Global Instrumentation, LLC.

What is the FDA product code for Matrix Data Management System?

The FDA product code for Matrix Data Management System is DXN.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Global Instrumentation, LLC

K152701Matrix Mini ECG Monitor K202456M5 Recorder

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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