510(k) K921002

RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED by Rondex Products, Inc. — Product Code BTM

K921002 is an FDA 510(k) premarket notification submitted by Rondex Products, Inc. for the device "RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED". The FDA issued a decision of Substantially Equivalent on October 6, 1992. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Rondex Products, Inc. has at least 10 other 510(k) clearances on record.