510(k) K963669

GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM by Astro-Med, Inc. — Product Code GWL

K963669 is an FDA 510(k) premarket notification submitted by Astro-Med, Inc. for the device "GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM". The FDA issued a decision of Substantially Equivalent on December 12, 1996. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Astro-Med, Inc. has at least 10 other 510(k) clearances on record.