Panels › Cardiovascular › Product code MLO · Class 2
Electrocardiograph, Ambulatory, With Analysis Algorithm
Regulation 870.2800
1510(k)s in 12 months (33 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MLO
| Company | 510(k)s | Recalls |
|---|---|---|
| Agilent Technologies | 3 | 0 |
| Inovise Medical, Inc. | 3 | 0 |
| Baxter Healthcare Corporation | 0 | 2 |
| Galix Biomedical Instrumentation, Inc. | 2 | 0 |
| Norav Medical , Ltd. | 2 | 0 |
| Novacor | 2 | 0 |
| Zymed Medical Instrumentation | 2 | 0 |
| Biomedical Systems Corp. | 1 | 0 |
| Bittium Biosignals , Ltd. | 1 | 0 |
| Brentwood Medical Technology Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2026 | K261580 | ZBPro Diagnostic (Version 2.0) Zbeats, Inc. | MLO |
| Mar 21, 2025 | K241890 | Philips Holter Analysis System Philips Medizin Systeme Böblingen GmbH, DE | MLO |
| Nov 8, 2024 | K240794 | Frontier X Plus Fourth Frontier Technologies Pvt, Ltd., IN | MLO |
| Sep 2, 2020 | K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System VivaQuant, Inc. | MLO |
| Aug 26, 2020 | K193177 | CER-S Cardiocalm, IT | MLO |
| Nov 8, 2018 | K182030 | Faros Mobile Bittium Biosignals , Ltd., FI | MLO |
| Dec 5, 2014 | K140847 | CARDIOSPY ECG HOLTER SYSTEMS Labtech Kft., HU | MLO |
| Nov 26, 2013 | K131897 | CV3000 HOLTER ANALYSIS SYSTEM Vales & Hills Biomedical Tech. , Ltd., CN | MLO |
| Oct 11, 2013 | K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) Inovise Medical, Inc. | MLO |
| Sep 20, 2012 | K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) Inovise Medical, Inc. | MLO |
| Nov 10, 2011 | K111487 | NH-301 AMBULATORY ECG ANALYSIS SOFTWARE Norav Medical Corp., IL | MLO |
| Oct 24, 2011 | K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) Inovise Medical, Inc. | MLO |
| Sep 30, 2011 | K101273 | DYNAMIC ECG SYSTEM MODEL TLC5000 Contec Medical System Co., Ltd., CN | MLO |
| Jul 9, 2010 | K092853 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM Galix Biomedical Instrumentation, Inc. | MLO |
| Jun 29, 2007 | K063339 | MEDICK MHM200 PERSONAL HEART MONITOR Medick Healthcare , Ltd. | MLO |
| Aug 25, 2006 | K062088 | PREMIER 11 HOLTER Diagnostic Monitoring Software | MLO |
| Sep 26, 2005 | K051730 | MATRIX HOLTER SYSTEM, MODEL M12 Global Instrumentation, LLC | MLO |
| Sep 2, 2005 | K042782 | SEER MC Ge Medical Systems Information Technologies | MLO |
| Mar 24, 2005 | K043454 | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 Medicomp, Inc. | MLO |
| Jan 19, 2005 | K042108 | VISTA PLUS Novacor, FR | MLO |
| Jun 10, 2004 | K040753 | R-TEST EVOLUTION 3 Novacor, FR | MLO |
| Jun 30, 2003 | K024323 | CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 Biomedical Systems Corp. | MLO |
| Jun 11, 2003 | K031466 | IQMARK DIGITAL HOLTER Brentwood Medical Technology Corp. | MLO |
| May 8, 2002 | K012712 | NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 Norav Medical , Ltd. | MLO |
| Oct 4, 2001 | K010396 | C. NET 2100 Cardionetics, Ltd. | MLO |
| Sep 28, 2001 | K010949 | 2010 PLUS HOLTER FOR WINDOWS Agilent Technologies | MLO |
| Jun 11, 2001 | K004017 | H-SCRIBE Mortara Instrument, Inc. | MLO |
| Mar 15, 2001 | K992706 | GALIX GBI -3S-LP Galix Biomedical Instrumentation, Inc. | MLO |
| Feb 8, 2001 | K003940 | 2010 PLUS HOLTER FOR WINDOWS Agilent Technologies | MLO |
| Jan 5, 2001 | K003763 | 2010 PLUS HOLTER FOR WINDOWS Agilent Technologies | MLO |
| Aug 4, 2000 | K993788 | R.TEST EVOLUTION Novacor Div. | MLO |
| Jul 28, 1999 | K992197 | MODIFICATION TO ZYMED HOLTER 2000 Zymed Medical Instrumentation | MLO |
| Apr 13, 1999 | K990170 | HOLTER 2000 Zymed Medical Instrumentation | MLO |
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