510(k) K961582

EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 by North American Technical Services Corp. — Product Code DTC

K961582 is an FDA 510(k) premarket notification submitted by North American Technical Services Corp. for the device "EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100". The FDA issued a decision of Substantially Equivalent on November 8, 1996. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. North American Technical Services Corp. has at least 8 other 510(k) clearances on record.