(453 days)
The HME-Booster™ makes it possible to feed additional moisture into the system during rne innie Dooter - manoon p specifically when the use of an HME alone is no longer adequate due to a patient's moisture deficit. Only use the Booster T-piece when the Booster heating element is used. The HME-Booster™ can be used with HME's for anesthesia and HME's for ICU, at flow rates between 2L and 12L per minute. The HMEanoother and hime sole purpose of optimizing the output of the HME. It can only be used at any time in combination with an HME. Not for use with pediatric applications, where at any time in combination or equal to 250 ml and the body weight is less than 20 kg.
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The provided text is a 510(k) premarket notification letter from the FDA for a device called "HME-Booster™". It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory approval notice, not a study report.
Therefore, I cannot extract the requested information from the provided text.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).