Home › Device types › MLO
Electrocardiograph, Ambulatory, With Analysis Algorithm
FDA product code MLO · Class 2 · Cardiovascular
228
Registered devices
23
Adverse events
2
Recalls
32
510(k) clearances
Devices with this code
HScribe — MORTARA INSTRUMENT, INC.Modality Manager — MORTARA INSTRUMENT, INC.Cardiospy ECG Holter System — LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű TársaságHScribe — MORTARA INSTRUMENT, INC.HScribe — MORTARA INSTRUMENT, INC.ER9W CDMA UNM — BRAEMAR MANUFACTURING, LLCHScribe — MORTARA INSTRUMENT, INC.HScribe — MORTARA INSTRUMENT, INC.Modality Manager — MORTARA INSTRUMENT, INC.HScribe — MORTARA INSTRUMENT, INC.Midmark IQholter EX Digital Holter — MIDMARK CORPORATIONMillennia Software — BRAEMAR MANUFACTURING, LLCMidmark IQholter® Digital Holter Recorder Kit — MIDMARK CORPORATIONHolter analysis software + Data base. Includes download device according to reco — NORAV MEDICAL LTD.Norav 1200 Series PC-ECG — NORAV MEDICAL LTD.Modality Manager — MORTARA INSTRUMENT, INC.Patient Cable — GLOBAL INSTRUMENTATION, LLCHScribe — MORTARA INSTRUMENT, INC.HScribe — MORTARA INSTRUMENT, INC.TelePatch Cardiac Monitor — MEDICOMP, INC.AT-Patch — ATsens Co., Ltd.Holter down load and review software. Includes download device according to reco — NORAV MEDICAL LTD.Modality Manager — MORTARA INSTRUMENT, INC.Pouch — GLOBAL INSTRUMENTATION, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-11 | Baxter Healthcare Corporation | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and |
| 2024-10-11 | Baxter Healthcare Corporation | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and |
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