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K Number
K964130
Device Name
AEROGEAR ASTHMA ACTION KIT
Manufacturer
MONAGHAN MEDICAL CORP.
Date Cleared
1997-01-10

(87 days)

Product Code
BZH
Regulation Number
868.1860
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

The AeroGear Asthma Action Kit is a product containing the AeroChamber Aerosol Holding Chamber, a TruZone Peak Flow Meter, and educational materials used in an asthma management program. This kit is intended to be marketed to hospitals, outpatient clinics and physicians.

AI/ML Overview

The provided text does not contain information about acceptance criteria, device performance, a study conducted to prove the device meets acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

The document is a 510(k) summary for a medical device (AeroGear Asthma Action Kit) submitted in 1997. It describes the device, its components (which are previously cleared devices), and its intended marketing audience. It does not include any performance data or a study design.

§ 868.1860 Peak-flow meter for spirometry.

(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).