3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM— 510(k) K092853

Name: FDA 510(k) clearance K092853
Creator: U.S. Food and Drug Administration
Published: 2010-07-09

Substantially Equivalent

Galix Biomedical Instrumentation, Inc.

FDA 510(k) clearance K092853 for 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM, Substantially Equivalent on 2010-07-09. Applicant: Galix Biomedical Instrumentation, Inc.. Device class: 2.

Clearance details

Applicant: Galix Biomedical Instrumentation, Inc.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2009-09-16
Decision date: 2010-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami Beach, FL, US

Download summary PDF View on FDA.gov ↗

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