510(k) K001692

NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 by Neurosoft, Inc. — Product Code JXE

K001692 is an FDA 510(k) premarket notification submitted by Neurosoft, Inc. for the device "NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8". The FDA issued a decision of Substantially Equivalent on November 24, 2000. The device falls under product code JXE (Device, Nerve Conduction Velocity Measurement), a Class II device regulated under 21 CFR 882.1550. Neurosoft, Inc. has at least 6 other 510(k) clearances on record.