Electrocardiograph, Ambulatory, With Analysis Algorithm
FDA product code MLO · 32 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.2800
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1999-04-13 – 2026-09-11
MLO
2026-09-11
MLO
2025-03-21
Philips Holter Analysis System
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MLO
2024-11-08
Frontier X Plus
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MLO
2020-09-02
RX-1 Rhythm Express Remote Cardiac Monitoring System
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MLO
2020-08-26
CER-S
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MLO
2018-11-08
Faros Mobile
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MLO
2013-11-26
CV3000 HOLTER ANALYSIS SYSTEM
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MLO
2013-10-11
AUDICOR CPAM WITH SDB (SINGLE SENSOR)
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MLO
2012-09-20
AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)
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MLO
2011-11-10
NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
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MLO
2011-10-24
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
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MLO
2011-09-30
DYNAMIC ECG SYSTEM MODEL TLC5000
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MLO
2010-07-09
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
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MLO
2007-06-29
MEDICK MHM200 PERSONAL HEART MONITOR
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MLO
2006-08-25
PREMIER 11 HOLTER
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MLO
2005-09-26
MATRIX HOLTER SYSTEM, MODEL M12
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MLO
2005-09-02
SEER MC
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MLO
2005-03-24
CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410
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MLO
2005-01-19
VISTA PLUS
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MLO
2004-06-10
R-TEST EVOLUTION 3
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MLO
2003-06-30
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
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MLO
2003-06-11
IQMARK DIGITAL HOLTER
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MLO
2002-05-08
NORAV HOLTER SYSTEM, MODEL NH-300 V1.07
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MLO
2001-10-04
C. NET 2100
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MLO
2001-09-28
2010 PLUS HOLTER FOR WINDOWS
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MLO
2001-06-11
H-SCRIBE
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MLO
2001-03-15
GALIX GBI -3S-LP
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MLO
2001-02-08
2010 PLUS HOLTER FOR WINDOWS
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MLO
2001-01-05
2010 PLUS HOLTER FOR WINDOWS
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MLO
2000-08-04
R.TEST EVOLUTION
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MLO
1999-07-28
MODIFICATION TO ZYMED HOLTER 2000
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MLO
1999-04-13
HOLTER 2000
View details →No matching devices.
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