LogoFDA 510(k) Search
K Number
K012939
Device Name
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER
Manufacturer
MONAGHAN MEDICAL CORP.
Date Cleared
2001-09-28

(28 days)

Product Code
CAF
Regulation Number
868.5630
Type
Special
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Collapsible Holding Chamber used as an accessory to administer meter dose inhalers to patients being mechanically ventilated.

Device Description

Not Found

AI/ML Overview

I'm sorry, but this document is a 510(k) clearance letter for a medical device (AeroVent II™ CHC Collapsible Holding Chamber), not a study report. It does not contain information about acceptance criteria, device performance, study design, or expert ground truth as requested in your prompt. This document primarily states that the device has been found substantially equivalent to legally marketed predicate devices for its stated indications for use.

§ 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).