510(k) K982986

TUBING BLOOD FLOW METER MODEL NUMBER HD-800 by Koven Technology, Inc. — Product Code DPW

K982986 is an FDA 510(k) premarket notification submitted by Koven Technology, Inc. for the device "TUBING BLOOD FLOW METER MODEL NUMBER HD-800". The FDA issued a decision of Substantially Equivalent on November 24, 1998. 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.