510(k) K861412

DIRECT READOUT MODULE ACCESSORY by E.I. Dupont DE Nemours & Co., Inc. — Product Code JQP

K861412 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DIRECT READOUT MODULE ACCESSORY". The FDA issued a decision of Substantially Equivalent on May 23, 1986. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.