510(k) K062119

HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 by Medical Products Mfg., LLC — Product Code DRM

K062119 is an FDA 510(k) premarket notification submitted by Medical Products Mfg., LLC for the device "HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100". The FDA issued a decision of Substantially Equivalent on September 22, 2006. The device falls under product code DRM (Compressor, Cardiac, External), a Class II device regulated under 21 CFR 870.5200.