510(k) K954397

BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY by Koven Technology, Inc. — Product Code DPW

K954397 is an FDA 510(k) premarket notification submitted by Koven Technology, Inc. for the device "BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY". The FDA issued a decision of Substantially Equivalent on March 29, 1996. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Koven Technology, Inc. has at least 10 other 510(k) clearances on record.