GALIX GBI -3S-LP

Electrocardiograph, Ambulatory, With Analysis Algorithm

GALIX BIOMEDICAL INSTRUMENTATION, INC.

The following data is part of a premarket notification filed by Galix Biomedical Instrumentation, Inc. with the FDA for Galix Gbi -3s-lp.

Pre-market Notification Details

Device IDK992706
510k NumberK992706
Device Name:GALIX GBI -3S-LP
ClassificationElectrocardiograph, Ambulatory, With Analysis Algorithm
Applicant GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 Miami Beach,  FL  33140
ContactJordan Gavrielides
CorrespondentJordan Gavrielides
GALIX BIOMEDICAL INSTRUMENTATION, INC. 2555 COLLINS AVE., C-5 Miami Beach,  FL  33140
Product CodeMLO  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-12
Decision Date2001-03-15

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