MLO

Product Code: MLO


Products Classified as MLO

881Electrocardiograph, Ambulatory, With Analysis AlgorithmMedical Magnetic Tape Recorder.

Total Product Life Cycle (TPLC) Devices

881Electrocardiograph, Ambulatory, With Analysis AlgorithmMedical Magnetic Tape Recorder.

FDA Consensus Standards

Electrocardiograph, Ambulatory, With Analysis Algorithm [37694]21 CFR §870.2800 🔎
Electrocardiograph, Ambulatory, With Analysis Algorithm [38117]21 CFR §870.2800 🔎

Pre-market Notifications for MLO

K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant Inc.
K193177CER-SCardioCalm
K182030Faros MobileBittium Biosignals Ltd.
K140847CARDIOSPY ECG HOLTER SYSTEMSLABTECH KFT.
K131897CV3000 HOLTER ANALYSIS SYSTEMVALES & HILLS BIOMEDICAL TECH. LTD.
K130660AUDICOR CPAM WITH SDB (SINGLE SENSOR)INOVISE MEDICAL, INC.
K120462AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)INOVISE MEDICAL, INC.
K111487NH-301 AMBULATORY ECG ANALYSIS SOFTWARENORAV MEDICAL CORP.
K110569AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)INOVISE MEDICAL, INC.
K101273DYNAMIC ECG SYSTEM MODEL TLC5000CONTEC MEDICAL SYSTEM CO., LTD.
K0928533 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SMGALIX BIOMEDICAL INSTRUMENTATION, INC.
K062088PREMIER 11 HOLTERDIAGNOSTIC MONITORING SOFTWARE
K051730MATRIX HOLTER SYSTEM, MODEL M12GLOBAL INSTRUMENTATION, LLC
K043454CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410MEDICOMP, INC.
K042782SEER MCGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

Global Unique Device Identification Database

00812345029857Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345029840Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345029826Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027334Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027280Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027273Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027266Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027259Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027242Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027235Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027228Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027211Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027204Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027198Electrocardiograph, Ambulatory, With Analysis Algorithm
00812345027181Electrocardiograph, Ambulatory, With Analysis Algorithm

Maude Adverse Events

ZYMED HOLTER SOFTWAREPHILIPS MEDICAL SYSTEMS2019-08-16
ER920W WIRELESS EVENT RECORDERBRAEMAR MANUFACTURING LLC2018-05-10
HOLTER MONITORPHILLIPS/COFFEY MEDICAL2017-10-31
ZYMED HOLTER SOFTWAREPHILIPS MEDICAL SYSTEMS2017-09-25
ZYMED HOLTER SOFTWAREPHILIPS MEDICAL SYSTEMS2014-05-05
ZYMED HOLTER SOFTWAREPHILIPS HEALTHCARE2011-03-21
NANAPHILIPS MEDICAL SYSTEMS2010-01-08
HOLTER 2010 PLUS SOFTWAREPHILIPS MEDICAL SYSTEMS2009-10-21
ZYMED HOLTER SOFTWAREPHILIPS MEDICAL SYSTEMS2009-10-02
ZYMED HOLTER SOFTWAREPHILIPS MEDICAL SYSTEMS2009-09-25
1810 HOLTER ANALYSIS SWPHILIPS MEDICAL SYSTEMS2009-08-19
HOLTER 2010 PLUS SOFTWAREPHILIPS HEALTHCARE2009-04-22
ZYMED DIGITRAK-PLUS 24ZYMED - PHILLIPS2004-03-25
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