510(k) K850137

TECA TC2-64 TRANSCRANIAL DOPPLER by Teca, Inc. — Product Code DPW

K850137 is an FDA 510(k) premarket notification submitted by Teca, Inc. for the device "TECA TC2-64 TRANSCRANIAL DOPPLER". The FDA issued a decision of Substantially Equivalent on August 14, 1985. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Teca, Inc. has at least 10 other 510(k) clearances on record.