(356 days)
The AHP300P is intended to be used as an electrically controlled emergency ventilator that requires an external compressed gas source. This ventilator is designed to provide emergency respiratory support by means of a face mask or tube inserted into the patients airway. The ventilator is intended for use on patients weighing greater than 5kg (11 lbs). The ventilator is intended to be used in the environments associated with emergency medical services (EMS), Inter-hospital transport and hospital facilities usage. The ventilator is intended to be used in temperatures of -18 C to 50 C (0 F to 122 F) and 5% to 95 % relative humidity non-condensing.
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The provided text is a 510(k) clearance letter from the FDA for a medical device called "AHP300P Emergency Portable Ventilator." This letter grants market clearance based on substantial equivalence to a predicate device and details the product name, regulation number, regulatory class, and product code.
However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
Therefore, I cannot fulfill your request for this information based on the provided input. This document is a regulatory clearance letter, not a detailed performance study report.
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).