510(k) K090811

INSPIRA HD, MODEL: NL1000 by Neurologica Corporation — Product Code KPS

K090811 is an FDA 510(k) premarket notification submitted by Neurologica Corporation for the device "INSPIRA HD, MODEL: NL1000". The FDA issued a decision of Substantially Equivalent on August 27, 2009. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Neurologica Corporation has at least 7 other 510(k) clearances on record.