510(k) K882278

RESUSCITATION BAG CONTROLLER (RBC) by Physician Engineered Products, Inc. — Product Code BTM

K882278 is an FDA 510(k) premarket notification submitted by Physician Engineered Products, Inc. for the device "RESUSCITATION BAG CONTROLLER (RBC)". The FDA issued a decision of Substantially Equivalent on June 16, 1988. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Physician Engineered Products, Inc. has at least 7 other 510(k) clearances on record.