510(k) K874758

DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE by Dantec Electronics, Inc. — Product Code FAP

K874758 is an FDA 510(k) premarket notification submitted by Dantec Electronics, Inc. for the device "DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on April 14, 1988. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Dantec Electronics, Inc. has at least 10 other 510(k) clearances on record.