510(k) K033130

PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR by Osypka Medical, Inc. — Product Code DTE

K033130 is an FDA 510(k) premarket notification submitted by Osypka Medical, Inc. for the device "PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR". The FDA issued a decision of Substantially Equivalent on October 31, 2003. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Osypka Medical, Inc. has at least 6 other 510(k) clearances on record.