510(k) K061639

ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON by Axon Systems, Inc. — Product Code GWF

K061639 is an FDA 510(k) premarket notification submitted by Axon Systems, Inc. for the device "ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON". The FDA issued a decision of Substantially Equivalent on November 1, 2006. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Axon Systems, Inc. has at least 10 other 510(k) clearances on record.