AEROGEAR ASTHMA ACTION KIT

K964130 · Monaghan Medical Corp. · BZH · Jan 10, 1997 · Anesthesiology

Device Facts

• Record ID: K964130
• Device Name: AEROGEAR ASTHMA ACTION KIT
• Applicant: Monaghan Medical Corp.
• Product Code: BZH · Anesthesiology
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

AeroGear Asthma Action Kit; contains AeroChamber Aerosol Holding Chamber, TruZone Peak Flow Meter, fanny pack, and educational materials. Used in clinical settings (hospitals, outpatient clinics) by physicians to facilitate asthma management programs. Kit components function as established in their respective clearances; AeroChamber delivers aerosolized medication; TruZone measures peak expiratory flow. Output used by clinicians to monitor patient respiratory status and manage asthma treatment plans.

Clinical Evidence

No clinical data; bench testing only via reliance on predicate device clearances.

Technological Characteristics

Kit assembly of two cleared medical devices. No modifications to individual device function or materials. Standalone components.

Indications for Use

Indicated for use in asthma management programs for patients requiring aerosol medication delivery and peak flow monitoring.

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Predicate Devices

• AeroChamber w/FLOWSIGnal (K872037/A)
• TruZone Peak Flow Meter (K926307)

Submission Summary (Full Text)

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K964130

JAN 10 1997

# SECTION 2 - SUMMARY AND CERTIFICATION

## 510(k) SUMMARY

Monaghan Medical Corporation
5 Latour Ave., Suite 1600
P.O. Box 2805
Plattsburgh, NY 12901-0299
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 the AeroChamber Aerosol Holding Chamber, TruZone Peak Flow Meter, a fanny pack and educational materials used in an asthma management program. This kit is intended to be marketed to hospitals, outpatient clinics and physicians.

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