510(k) K800990

TRACH MIST UNIT W/OR WITHOUT ELBOW by Airlife, Inc. — Product Code BYH

K800990 is an FDA 510(k) premarket notification submitted by Airlife, Inc. for the device "TRACH MIST UNIT W/OR WITHOUT ELBOW". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code BYH (Drain, Tee (Water Trap)), a Class I device regulated under 21 CFR 868.5995. Airlife, Inc. has at least 10 other 510(k) clearances on record.