510(k) K780717

EXTERNAL TEST PULSE GENERATOR by Vitatron Medical BV — Product Code DTC

K780717 is an FDA 510(k) premarket notification submitted by Vitatron Medical BV for the device "EXTERNAL TEST PULSE GENERATOR". The FDA issued a decision of Substantially Equivalent on June 30, 1978. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. Vitatron Medical BV has at least 10 other 510(k) clearances on record.