APEX MEDICAL MOBINEB, 9R-027 SERIES

• K Number: K070990
• Device Name: APEX MEDICAL MOBINEB, 9R-027 SERIES
• Manufacturer: APEX MEDICAL CORP.
• Date Cleared: 2007-05-18 ( 39 days)
• Product Code: CAF
• Regulation Number: 868.5630
• Type: Special
• Panel: Anesthesiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The 9R-027XXX Series, MobiNeb 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.

Device Description

Not Found

AI/ML Overview

This document is primarily a 510(k) clearance letter from the FDA for a nebulizer. It does not contain information about acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot provide the requested information based on the provided 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).