BodyGuardian Remote Monitoring System - K151188 on Sep-17-2015
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The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, In-hospital monitoring for life threatening arrhythmias. The Preventice BodyGuardian Remote Monitoring System is intended for use with adult patients in clinical and non‐clinical settings to collect and transmit health parameters to healthcare professionals for monitoring and evaluation. Health parameters are collected from a variety of commercially available, external plug in devices such as ECG sensors, Weight Scales, Blood Pressure Meters and Pulse Oximeters.  The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.

DSI Traditional 510k
2017
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