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Electrocardiograph, Ambulatory, With Analysis Algorithm

FDA product code MLO · Class 2 · Cardiovascular

229
Registered devices
24
Adverse events
2
Recalls
33
510(k) clearances

Devices with this code

Millennia Software — BRAEMAR MANUFACTURING, LLCMillennia Software — BRAEMAR MANUFACTURING, LLCWelch Allyn, Inc. — WELCH ALLYN, INC.Millennia Software — BRAEMAR MANUFACTURING, LLCWelch Allyn, Inc. — WELCH ALLYN, INC.Modality Manager — MORTARA INSTRUMENT, INC.AT-Patch — ATsens Co., Ltd.Welch Allyn, Inc. — WELCH ALLYN, INC.Cardiospy ECG Holter System — LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű TársaságMidmark IQholter® Electrodes — MIDMARK CORPORATIONWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.HScribe — MORTARA INSTRUMENT, INC.Cardiospy ECG Holter System — LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű TársaságHScribe — MORTARA INSTRUMENT, INC.HScribe — MORTARA INSTRUMENT, INC.Modality Manager — MORTARA INSTRUMENT, INC.HScribe — MORTARA INSTRUMENT, INC.Scribe — MORTARA INSTRUMENT, INC.HScribe — MORTARA INSTRUMENT, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Millennia Software — BRAEMAR MANUFACTURING, LLCER9W CDMA UNM — BRAEMAR MANUFACTURING, LLC

Recent recalls

DateFirmReason
2024-10-11Baxter Healthcare CorporationThere is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and
2024-10-11Baxter Healthcare CorporationThere 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.