3 results
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72ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
FDA Enforcement
Class II
·Terminated·Braemar Manufacturing, LLC·March 18, 2020
Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
FDA Enforcement
Class II
·Terminated·Braemar Manufacturing, LLC·March 18, 2020
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
FDA Enforcement
Class I
·Ongoing·Braemar Manufacturing, LLC·January 1, 2025