AEROGEAR ASTHMA ACTION KIT

• 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: Anesthesiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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.

Summary

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K964130

JAN 1 0 1997

SECTION 2 - SUMMARY AND CERTIFICATION

510 (k) SUMMARY

Monaghan Medical Corporation 5 Latour Ave., Suite 1600 P.O. Box 2805 12901-0299 Plattsburgh, NY Phone: [phone] Fax: [phone] Contact: James A. Cochie QA/RA Manager

Date Prepared: October 1, 1996

Device Proprietary Name: AeroGear Asthma Action Kit Device Classification name: Unknown

Legally Marketed Device Identity:

AeroChamber w/FLOWSIGnal, 510(k) #872037/A TruZone Peak Flow Meter, 510(k) #926307

Device Description:

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

The two devices indicated above are currently marketed devices which have been cleared through the 510(k) process.

Regulation Number and Section

§ 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).