510(k) K881931

RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR by Rondex Products, Inc. — Product Code CBP

K881931 is an FDA 510(k) premarket notification submitted by Rondex Products, Inc. for the device "RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR". The FDA issued a decision of Substantially Equivalent on July 21, 1988. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Rondex Products, Inc. has at least 10 other 510(k) clearances on record.