(283 days)
The Foshan Care Medical Nebulizer Compressor, Model K Y WH2001, includes an AC powered air compressor that provides a source of compressed air. The compressor is used in conjunction with the Hsiner Disposable Nebulizer, Model Number HS-31100, to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The Foshan Care Medical Nebulizer Compressor, Model KY WH2001 is intended to aerosolize physician- prescribed solutions for inhalation that are approved for nebulization. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001 is intended for adult and pediatric patients consistent with the indications for the aerosol medication. The Foshan Care Medical Nebulizer Compressor, Model KYWH2001, is not intended for life support nor does it provide any patient monitoring capabilities.
Not Found
The provided document is an FDA 510(k) clearance letter for a Medical Nebulizer Compressor. It does not contain any information regarding the acceptance criteria, study details, or performance metrics for the device as outlined in your request.
The letter primarily focuses on the substantial equivalence determination for the nebulizer compressor to a predicate device, as per FDA regulations.
Therefore, I cannot provide the requested information about acceptance criteria and study details based on the given text. The document is essentially a regulatory approval letter and not a technical or clinical 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).