510(k) K941547

CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT by Allied Healthcare Products, Inc. — Product Code BYK

K941547 is an FDA 510(k) premarket notification submitted by Allied Healthcare Products, Inc. for the device "CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT". The FDA issued a decision of Substantially Equivalent on March 1, 1995. The device falls under product code BYK (Tent, Oxygen, Electrically Powered), a Class II device regulated under 21 CFR 868.5710. Allied Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.