AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C

• K Number: K053360
• Device Name: AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
• Manufacturer: AEROVECTRX CORPORATION
• Date Cleared: 2006-03-23 ( 111 days)
• Product Code: CAF
• Regulation Number: 868.5630
• Type: Traditional
• Panel: Anesthesiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

To be used to convert liquid medication into aerosol for inhalation by patients.

Device Description

Not Found

AI/ML Overview

The provided text describes an FDA 510(k) clearance for the AeroLife Model P2C Ultrasonic Nebulizer. It does not contain information about acceptance criteria for a device's performance, nor does it detail a study proving such criteria are met. The document is a regulatory approval letter, not a scientific study report.

Therefore, I cannot provide the requested information based on the given text.

Regulation Number and Section

§ 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).