(283 days)
The RTC Series Metered Dose Inhaler (MDI) Adapters are actuators for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers. The RTC Series MDI Adapters are intended for use only when connected to ventilator tubing or tracheal tubes.
The RTC 15-D, RTC 22-D, and RTC 23-D models are intended for single patient use.
The RTC 22-A and RTC 23-A models are reusable and may be reprocessed.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a Metered Dose Inhaler Adapter (K991355). It does not contain information about acceptance criteria, study details, or performance data for the device. The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information. This document is a regulatory clearance letter, not a study report or technical specification.
§ 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).