Koven Technology, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K201114Bidop 7January 5, 2021
K153762Smartdop XT6May 25, 2016
K143332Fast Sphyg by KovenApril 14, 2015
K131623SMARTDOP XTJanuary 17, 2014
K080178VALVULOTOME BY KOVENJuly 28, 2008
K050601SMARTDOP 45 VASCULAR DOPPLERApril 15, 2005
K031931ECHO SOUNDER EX-101EX 8 MHZFebruary 13, 2004
K031504ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EXJuly 18, 2003
K023143ECHO SOUNDER, ES-102EXDecember 19, 2002
K010452BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300TFebruary 12, 2002
K982986TUBING BLOOD FLOW METER MODEL NUMBER HD-800November 24, 1998
K961817B SMART MODEL 1July 23, 1997
K963274V-LINK 3.2 FOR WINDOWSOctober 31, 1996
K951449MODEL KM-25May 20, 1996
K954397BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAYMarch 29, 1996
K935994PW DOPPLER VASCULAR PROBESMay 11, 1995
K942613SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTORDecember 23, 1994
K934638REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8May 13, 1994