510(k) K812022

ZEE MANUAL RESUSCITATOR by Zee Medical Products Co., Inc. — Product Code BTM

K812022 is an FDA 510(k) premarket notification submitted by Zee Medical Products Co., Inc. for the device "ZEE MANUAL RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on July 31, 1981. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Zee Medical Products Co., Inc. has at least 7 other 510(k) clearances on record.