510(k) K821673

HEART*AID, ALS, MODEL 95 by Cardiac Resucitator Corp. — Product Code DRO

K821673 is an FDA 510(k) premarket notification submitted by Cardiac Resucitator Corp. for the device "HEART*AID, ALS, MODEL 95". The FDA issued a decision of Substantially Equivalent on August 6, 1982. The device falls under product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)), a Class II device regulated under 21 CFR 870.5550. Cardiac Resucitator Corp. has at least 10 other 510(k) clearances on record.