MATRIX HOLTER SYSTEM, MODEL M12— 510(k) K051730

Name: FDA 510(k) clearance K051730
Creator: U.S. Food and Drug Administration
Published: 2005-09-26

Substantially Equivalent

Global Instrumentation, LLC

FDA 510(k) clearance K051730 for MATRIX HOLTER SYSTEM, MODEL M12, Substantially Equivalent on 2005-09-26. Applicant: Global Instrumentation, LLC. Device class: 2.

Clearance details

Applicant: Global Instrumentation, LLC
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2005-06-27
Decision date: 2005-09-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Manlius, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.