(447 days)
Stronghealth Compressor Nebulizer MCN-S600XX is used to administer various aerosol treatments of all Subgream Compressor Nebulizer MCN-30007X is 350 a idinister or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
The intended environment for use of the product is in the patient's home on the order of a physician.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Stronghealth Compressor Nebulizer MCN-S600XX." It primarily addresses the device's substantial equivalence to a predicate device and its regulatory classification. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information, as it is not present in the provided text. The document is a regulatory approval letter, not a performance study report.
§ 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).