(29 days)
The 9R-02X Series, MiniNeb & MiniPlus are designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine
9R-02X Series, MiniNeb & MiniPlus
The provided document is a 510(k) clearance letter from the FDA for a nebulizer device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter focuses on:
- Confirming that the device (9R-02X Series, MiniNeb & MiniPlus) is substantially equivalent to legally marketed predicate devices.
- Outlining the regulatory requirements that the manufacturer must adhere to (e.g., annual registration, listing, good manufacturing practices, labeling).
- Stating the intended use of the device.
Therefore, I cannot provide the requested information based on the input text. The document is solely a regulatory clearance communication, not a technical report detailing performance studies.
§ 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).