(250 days)
The Ambu MediBag Adult Resuscitator is intended for pulmonary resuscitation of adult patients with a body weight of more than 66 lbs (30 kg) and for administration of inhaled B-adrenergic agonist for emergency patients in acute asthma.
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This document is a 510(k) clearance letter from the FDA for the Ambu MediBag Adult and Infant/Child Resuscitator. It primarily focuses on regulatory approval and does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving those criteria.
Therefore, I cannot provide the requested information from this document. The document confirms the device is substantially equivalent to a predicate device and meets the requirements of ASTM F920-93 (with one exception for temperature range) but does not elaborate on the specific studies or data mentioned in your questions.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).