(46 days)
Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM). the device is intended for use within the hospital or institutional environment.
Aladdin Monitoring Oxygen/Air Mixer is intended to mix and air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmeter (1 to 10 LPM).
This document is a 510(k) premarket notification letter from the FDA to Hamilton Medical, Inc. for the Aladdin II Monitoring Oxygen/Air Mixer. It primarily discusses the regulatory classification and marketing authorization for the device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about device performance, sample sizes, ground truth establishment, or expert reviews as requested in the prompt.
Therefore, I cannot provide the requested information based on the given text. The text does not describe a study or device performance data.
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).