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510(k) Data Aggregation
K Number
K081062Device Name
AIRSONNETT AIRSHOWER AIR 3
Manufacturer
AIRSONETT, INC.
Date Cleared
2008-11-07
(207 days)
Product Code
FRF
Regulation Number
880.5045Why did this record match?
Applicant Name (Manufacturer) :
AIRSONETT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Airsonett Airshower Air 3 is a Mobile Air Cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for home use only.
Device Description
The Airsonett Airshower Air 3 Mobile Medical Air Cleaner is an adjustable, portable, personal system for use in providing a controlled environment for medical applications that require a high degree of airborne particulate control. The system is controlled by embedded firmware and runs on standard 115 volt, 1.7 ampere power. Pushbutton controls include airflow and cooling capacity. Manual controls include till/angle of air outflow.
The Airsonett Airshower Air 3 Mobile Medical Air Cleaner device provides a method, using air cooling, for guiding the treated ambient air so as to obtain an air flow distribution directly to the users breathing zone, thereby forming a treated air zone surrounding the user.
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