510(k) K945657

DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER by Tec II Medical, Inc. — Product Code BYD

K945657 is an FDA 510(k) premarket notification submitted by Tec II Medical, Inc. for the device "DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER". The FDA issued a decision of Substantially Equivalent on December 7, 1994. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Tec II Medical, Inc. has at least 1 other 510(k) clearance on record.