Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Global Instrumentation, LLC. It received FDA 510(k) clearance on 2017-05-24 under 510(k) 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. The listed applicant is Global Instrumentation, LLC. The 510(k) number is K162463.

When did Matrix Data Management System receive FDA 510(k) clearance?

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

Who is the listed applicant for Matrix Data Management System?

The FDA 510(k) record lists Global Instrumentation, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Global Instrumentation, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252840M12 Telemetry SystemK202456M5 RecorderK152701Matrix Mini ECG Monitor

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

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.

↑