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The Evo Heated Humidifier is intended to warm and add moisture to the breathing gases for administration to a patient. It is used for patients requiring Continuous Positive Airway Pressure (CPAP) therapy for the treatment of Obstructive Sleep Apnea. The addition of heated humidification to this therapy relieves the drying and irritating effects on the patient airways, which may arise from the use of a CPAP system. Use only with RemRest 900 series CPAP devices. It is portable and is intended to be used in the home, hospital, and institutional settings.

The RemRest Heated Humidifier is a simple heated humidifier to be used with a CPAP device to provide heated and humidified air to the patient. It operates by a conductive heating surface warming a water reservoir and air passes over the water. The device has the following basic specifications: Size 13.1" L x 8.4" W x 4.7" H, Weight 2.5 lbs. dry, Water capacity 400 ml (1 2/3 cups), Power 100-240 VAC 50/60Hz or 1.0 A max., Heater setting 1-5 (85°F to 149°F / 29.4°C to 65°C), Humidity Range 30 mg H2O/l @ 25 lpm, Pressure drop 0.5 cm H2O @ 40 lpm.

The provided text is a summary of safety and effectiveness for the RemRest heated humidifier and does not describe acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.

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