510(k) K000812

NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE) by Neurosoft, Inc. — Product Code IKN

K000812 is an FDA 510(k) premarket notification submitted by Neurosoft, Inc. for the device "NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)". The FDA issued a decision of Substantially Equivalent on May 17, 2000. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375. Neurosoft, Inc. has at least 6 other 510(k) clearances on record.