510(k) K854012

AMERICAN PHARMASEAL HUMIDAIR CONDENSER by American Pharmaseal Div. Ahsc — Product Code BYD

K854012 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "AMERICAN PHARMASEAL HUMIDAIR CONDENSER". The FDA issued a decision of Substantially Equivalent on December 3, 1985. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.