Search Results

The Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP, a prescription device for use in the home, that is used by an adult (>30 kg) who has been diagnosed with Obstructive Sleep Apnea (OSA).

The intended function and use of the heated humidifier is to provide moisture to the patient circuit in order to improve patient comfort.

The Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP, a prescription device for use in the home, that is used by an adult (>30 kg) who has been diagnosed with Obstructive Sleep Apnea (OSA).

The intended function and use of the heated humidifier is to provide moisture to the patient circuit in order to improve patient comfort. The addition of heated humidification relieves the drying and irritating effects on the patient airways, which may result from the use of a CPAP system.

The provided text is a 510(k) summary for the Invacare Polaris EX Heated Humidifier. It details the device's intended use, description, and regulatory information, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification to the FDA, focused on establishing substantial equivalence to a predicate device. It does not include performance data or studies against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device