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Airsonett AIR-4

Airsonett AB · Model 4 · UDI-DI 07350128750015

FRF
1
510(k) clearances
31
Adverse events
1
Recalls
11
Facilities

Description

Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.

Recalls

DateFirmReason
2012-01-09Healthway Home Products, Inc.The Company is recalling certain serial numbers of HealthWay Model 20600-3 and CleanStation Model CS20000 air purifiers because of a potential risk of electrical arcing that could

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.