Electrocardiograph, Ambulatory, With Analysis Algorithm
The Ambulatory Electrocardiograph with Analysis Algorithm is a wearable or portable ECG recorder designed for extended monitoring periods, typically 24 to 48 hours or longer, that captures the patient's cardiac rhythm during daily activities and incorporates automated analysis algorithms to detect and classify arrhythmias, ST segment changes, or other abnormalities. Classified as a Class 2 device under 21 CFR 870.2800 within the Cardiovascular specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MLO
- Device Class
- FDA class 2
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 32 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K241890 | Philips Holter Analysis System | Mar 21, 2025 | Substantially Equivalent | Philips Medizin Systeme Böblingen GmbH |
| K240794 | Frontier X Plus | Nov 08, 2024 | Substantially Equivalent | Fourth Frontier Technologies Pvt, Ltd. |
| K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | Sep 02, 2020 | Substantially Equivalent | VivaQuant, Inc. |
| K193177 | CER-S | Aug 26, 2020 | Substantially Equivalent | Cardiocalm |
| K182030 | Faros Mobile | Nov 08, 2018 | Substantially Equivalent | Bittium Biosignals , Ltd. |
| K140847 | CARDIOSPY ECG HOLTER SYSTEMS | Dec 05, 2014 | Substantially Equivalent | Labtech Kft. |
| K131897 | CV3000 HOLTER ANALYSIS SYSTEM | Nov 26, 2013 | Substantially Equivalent | Vales & Hills Biomedical Tech. , Ltd. |
| K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | Oct 11, 2013 | Substantially Equivalent | Inovise Medical, Inc. |
| K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) | Sep 20, 2012 | Substantially Equivalent | Inovise Medical, Inc. |
| K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | Nov 10, 2011 | Substantially Equivalent | Norav Medical Corp. |
| K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | Oct 24, 2011 | Substantially Equivalent | Inovise Medical, Inc. |
| K101273 | DYNAMIC ECG SYSTEM MODEL TLC5000 | Sep 30, 2011 | Substantially Equivalent | Contec Medical System Co., Ltd. |
| K092853 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM | Jul 09, 2010 | Substantially Equivalent | Galix Biomedical Instrumentation, Inc. |
| K063339 | MEDICK MHM200 PERSONAL HEART MONITOR | Jun 29, 2007 | Substantially Equivalent | Medick Healthcare , Ltd. |
| K062088 | PREMIER 11 HOLTER | Aug 25, 2006 | Substantially Equivalent | Diagnostic Monitoring Software |
| K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | Sep 26, 2005 | Substantially Equivalent | Global Instrumentation, LLC |
| K042782 | SEER MC | Sep 02, 2005 | Substantially Equivalent | Ge Medical Systems Information Technologies |
| K043454 | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 | Mar 24, 2005 | Substantially Equivalent | Medicomp, Inc. |
| K042108 | VISTA PLUS | Jan 19, 2005 | Substantially Equivalent | Novacor |
| K040753 | R-TEST EVOLUTION 3 | Jun 10, 2004 | Substantially Equivalent | Novacor |
| K024323 | CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 | Jun 30, 2003 | Substantially Equivalent | Biomedical Systems Corp. |
| K031466 | IQMARK DIGITAL HOLTER | Jun 11, 2003 | Substantially Equivalent | Brentwood Medical Technology Corp. |
| K012712 | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 | May 08, 2002 | Substantially Equivalent | Norav Medical , Ltd. |
| K010396 | C. NET 2100 | Oct 04, 2001 | Substantially Equivalent | Cardionetics, Ltd. |
| K010949 | 2010 PLUS HOLTER FOR WINDOWS | Sep 28, 2001 | Substantially Equivalent | Agilent Technologies |
| K004017 | H-SCRIBE | Jun 11, 2001 | Substantially Equivalent | Mortara Instrument, Inc. |
| K992706 | GALIX GBI -3S-LP | Mar 15, 2001 | Substantially Equivalent | Galix Biomedical Instrumentation, Inc. |
| K003940 | 2010 PLUS HOLTER FOR WINDOWS | Feb 08, 2001 | Substantially Equivalent | Agilent Technologies |
| K003763 | 2010 PLUS HOLTER FOR WINDOWS | Jan 05, 2001 | Substantially Equivalent | Agilent Technologies |
| K993788 | R.TEST EVOLUTION | Aug 04, 2000 | Substantially Equivalent | Novacor Div. |
| K992197 | MODIFICATION TO ZYMED HOLTER 2000 | Jul 28, 1999 | Substantially Equivalent | Zymed Medical Instrumentation |
| K990170 | HOLTER 2000 | Apr 13, 1999 | Substantially Equivalent | Zymed Medical Instrumentation |
FEI Numbers
This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.