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Home » Dräger Medical Receives 510(k) Clearance for Monitoring Device
Dräger Medical Receives 510(k) Clearance for Monitoring Device
Dräger Medical announced it received 510(k) clearance for its Infinity TeleSmart system featuring a compact device that monitors electrocardiogram (ECG) readings and peripheral oxygen saturation.
The Infinity addresses three major challenges of electronic data transmissions, Dräger said.
These are: Viewing patient information at the patient's side. The Infinity TeleSmart has a color display showing the patient's ECG for all monitored leads, heart rate, peripheral oxygen saturation and electrode status;Hearing and managing alarms. The device has built-in alarming and alarm controls, which provide alarm alerts both at the patient's side and the central monitoring system; andCost and effort associated with disposable batteries. Infinity TeleSmart has a built-in rechargeable battery that can be recharged via a bedside charger or at the central monitoring station.
The device can be worn by adults and pediatric patients, the company said.
KEYWORDS FDAnews Device Daily Bulletin
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