510(k) K972203

BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT by Allied Healthcare Products, Inc. — Product Code CBK

K972203 is an FDA 510(k) premarket notification submitted by Allied Healthcare Products, Inc. for the device "BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT". The FDA issued a decision of ST on November 6, 1997. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Allied Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.