510(k) K952169

SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC by Intertech Resources, Inc. — Product Code BTM

K952169 is an FDA 510(k) premarket notification submitted by Intertech Resources, Inc. for the device "SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC". The FDA issued a decision of Substantially Equivalent on June 8, 1995. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Intertech Resources, Inc. has at least 10 other 510(k) clearances on record.