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510(k) K992706

Device
GALIX GBI -3S-LP
Applicant
GALIX BIOMEDICAL INSTRUMENTATION, INC.
510(k) number
K992706
Product code
MLO  
Decision
Substantially Equivalent (SESE)
Decision date
2001-03-15
Date received
1999-08-12
Regulation
870.2800
Classification name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JORDAN GAVRIELIDES
Address
2555 Collins Ave., C-5 Miami Beach FL US 33140 33140

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MLO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbH2025-03-21
K240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.2024-11-08
K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.2020-09-02
K193177CER-SCardiocalm2020-08-26
K182030Faros MobileBittium Biosignals , Ltd.2018-11-08
K140847CARDIOSPY ECG HOLTER SYSTEMSLabtech Kft.2014-12-05
K131897CV3000 HOLTER ANALYSIS SYSTEMVales & Hills Biomedical Tech. , Ltd.2013-11-26
K130660AUDICOR CPAM WITH SDB (SINGLE SENSOR)Inovise Medical, Inc.2013-10-11
K120462AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)Inovise Medical, Inc.2012-09-20
K111487NH-301 AMBULATORY ECG ANALYSIS SOFTWARENorav Medical Corp.2011-11-10
K110569AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)Inovise Medical, Inc.2011-10-24
K101273DYNAMIC ECG SYSTEM MODEL TLC5000Contec Medical System Co., Ltd.2011-09-30
K0928533 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SMGalix Biomedical Instrumentation, Inc.2010-07-09
K063339MEDICK MHM200 PERSONAL HEART MONITORMedick Healthcare , Ltd.2007-06-29
K062088PREMIER 11 HOLTERDiagnostic Monitoring Software2006-08-25

Legacy Summary#

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FDA Review#

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