MLO — Electrocardiograph, Ambulatory, With Analysis Algorithm Class II
FDA product code MLO covers "Electrocardiograph, Ambulatory, With Analysis Algorithm", a Class II medical device regulated under 21 CFR 870.2800. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |