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Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.

Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.

This document is a 510(k) clearance letter for the Ventlab Hyperinflation Bag System. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed devices. It outlines regulatory requirements and provides contact information for further inquiries.

Therefore, I cannot provide the requested information about acceptance criteria and the study based on the provided text.

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