FDA Device Intelligence
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Electrocardiograph, Ambulatory (Without Analysis)

FDA product code MWJ · Class 2 · Cardiovascular

467
Registered devices
63
Adverse events
5
Recalls
64
510(k) clearances

Devices with this code

Eclipse Pro — SPACELABS HEALTHCARE (WASHINGTON), INCECG Cable for CM 3000-12 BT / SEER 12 10 Leads — getemed Medizin- und Informationstechnik AGSEER — SUZUKEN CO., LTD.H3+ Patient Cable — MORTARA INSTRUMENT, INC.Chroma — SCOTTCARE CORPORATION, THEEclipse Pro — SPACELABS HEALTHCARE (WASHINGTON), INCPER900 Braemar — BRAEMAR MANUFACTURING, LLCWelch Allyn, Inc. — WELCH ALLYN, INC.Welch Allyn, Inc. — WELCH ALLYN, INC.Eclipse Pro — SPACELABS HEALTHCARE (WASHINGTON), INCDR181 — Northeast Monitoring, Inc.Norav NR Series — NORAV MEDICAL LTD.SEER 1000 — getemed Medizin- und Informationstechnik AGEclipse Pro — SPACELABS HEALTHCARE (WASHINGTON), INCECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AGSpacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INCEVO — SPACELABS HEALTHCARE (WASHINGTON), INCNorav NR Series — NORAV MEDICAL LTD.Welch Allyn, Inc. — WELCH ALLYN, INC.Chroma 7 Lead Patient Cable — SCOTTCARE CORPORATION, THEWelch Allyn, Inc. — WELCH ALLYN, INC.DL900 Amedtec SD — BRAEMAR MANUFACTURING, LLCBiotres Pro — BIOTRICITY INCSpacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INC

Recent recalls

DateFirmReason
2024-11-25Spacelabs Healthcare, Ltd.Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the de
2024-11-25Spacelabs Healthcare, Ltd.Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the de
2020-01-22Braemar Manufacturing, LLCAn issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar
2020-01-22Braemar Manufacturing, LLCAn issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar
2020-01-13Philips North America, LLCif an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.