MLO — Electrocardiograph, Ambulatory, With Analysis Algorithm Class II
FDA Device Classification
Classification Details
- Product Code
- MLO
- Device Class
- Class II
- Regulation Number
- 870.2800
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K241890 | philips medizin systeme böblingen | Philips Holter Analysis System | March 21, 2025 |
| K240794 | fourth frontier technologies pvt | Frontier X Plus | November 8, 2024 |
| K200833 | vivaquant | RX-1 Rhythm Express Remote Cardiac Monitoring System | September 2, 2020 |
| K193177 | cardiocalm | CER-S | August 26, 2020 |
| K182030 | bittium biosignals | Faros Mobile | November 8, 2018 |
| K140847 | labtech kft | CARDIOSPY ECG HOLTER SYSTEMS | December 5, 2014 |
| K131897 | vales and hills biomedical tech. | CV3000 HOLTER ANALYSIS SYSTEM | November 26, 2013 |
| K130660 | inovise medical | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | October 11, 2013 |
| K120462 | inovise medical | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED | September 20, 2012 |
| K111487 | norav medical | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE | November 10, 2011 |
| K110569 | inovise medical | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | October 24, 2011 |
| K101273 | contec medical system co | DYNAMIC ECG SYSTEM MODEL TLC5000 | September 30, 2011 |
| K092853 | galix biomedical instrumentation | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM | July 9, 2010 |
| K063339 | medick healthcare | MEDICK MHM200 PERSONAL HEART MONITOR | June 29, 2007 |
| K062088 | diagnostic monitoring software | PREMIER 11 HOLTER | August 25, 2006 |
| K051730 | global instrumentation | MATRIX HOLTER SYSTEM, MODEL M12 | September 26, 2005 |
| K042782 | ge medical systems information technologies | SEER MC | September 2, 2005 |
| K043454 | medicomp | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 | March 24, 2005 |
| K042108 | novacor | VISTA PLUS | January 19, 2005 |
| K040753 | novacor | R-TEST EVOLUTION 3 | June 10, 2004 |