(226 days)
The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and medical nebulizer used as prescribed by a physician for medication in the home or health care facility.
The EMG NBA02-XXX Series Compressor Nebulizer is a compact medical nebulizing device intended for professional use containing a compressor and medical nebulizer.
This document is a 510(k) premarket notification letter from the FDA to EMG Technology Company Limited regarding their EMG NBA02-XXX Compressor Nebulizer. It states that the device has been found substantially equivalent to legally marketed predicate devices and can be marketed.
This document does not contain information about acceptance criteria or a study proving that the device meets those criteria. It is a regulatory approval document, not a scientific study or performance report. Therefore, I cannot extract the requested information from the provided text.
§ 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).