3 CHANNEL DIGITAL AMBULATORY ECG RECORDER

Recorder, Magnetic Tape, Medical

GALIX BIOMEDICAL INSTRUMENTATION, INC.

The following data is part of a premarket notification filed by Galix Biomedical Instrumentation, Inc. with the FDA for 3 Channel Digital Ambulatory Ecg Recorder.

Pre-market Notification Details

Device IDK971670
510k NumberK971670
Device Name:3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
ClassificationRecorder, Magnetic Tape, Medical
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 CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-06
Decision Date1998-01-29

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