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510(k) K162463

Matrix Data Management System by Global Instrumentation, LLC — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2017
Date Received
September 2, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Global Instrumentation, LLC

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  • K152701 — Matrix Mini ECG Monitor (April 22, 2016)
  • K051730 — MATRIX HOLTER SYSTEM, MODEL M12 (September 26, 2005)

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