Medical Device Manufacturer · US , St. Louis , MO

Koven Technology, Inc. - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 1994
18
Total
18
Cleared
0
Denied

Koven Technology, Inc. has 18 FDA 510(k) cleared medical devices. Based in St. Louis, US.

Last cleared in 2021. Active since 1994. Primary specialty: Radiology.

Browse the FDA 510(k) cleared devices submitted by Koven Technology, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Delphi Consulting Group as regulatory consultant.

FDA 510(k) Regulatory Record - Koven Technology, Inc.

18 devices
1-18 of 18
Cleared Jan 05, 2021
Bidop 7
K201114 · DPW
Cardiovascular · 253d
Cleared May 25, 2016
Smartdop XT6
K153762 · JOP
Cardiovascular · 147d
Cleared Apr 14, 2015
Fast Sphyg by Koven
K143332 · DXQ
Cardiovascular · 145d
Cleared Jan 17, 2014
SMARTDOP XT
K131623 · JOP
Cardiovascular · 227d
Cleared Jul 28, 2008
VALVULOTOME BY KOVEN
K080178 · MGZ
Cardiovascular · 186d
Cleared Apr 15, 2005
SMARTDOP 45 VASCULAR DOPPLER
K050601 · DPW
Radiology · 37d
Cleared Feb 13, 2004
ECHO SOUNDER EX-101EX 8 MHZ
K031931 · DPW
Cardiovascular · 235d
Cleared Jul 18, 2003
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
K031504 · KNG
Radiology · 65d
Cleared Dec 19, 2002
ECHO SOUNDER, ES-102EX
K023143 · KNG
Radiology · 90d
Cleared Feb 12, 2002
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
K010452 · DPW
Cardiovascular · 362d
Cleared Nov 24, 1998
TUBING BLOOD FLOW METER MODEL NUMBER HD-800
K982986 · DPW
Radiology · 90d
Cleared Jul 23, 1997
B SMART MODEL 1
K961817 · LEL
Neurology · 439d
Cleared Oct 31, 1996
V-LINK 3.2 FOR WINDOWS
K963274 · IYO
Radiology · 72d
Cleared May 20, 1996
MODEL KM-25
K951449 · IYO
Radiology · 418d
Cleared Mar 29, 1996
BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY
K954397 · DPW
Radiology · 191d
Cleared May 11, 1995
PW DOPPLER VASCULAR PROBES
K935994 · ITX
Radiology · 512d
Cleared Dec 23, 1994
SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR
K942613 · DPW
Radiology · 204d
Cleared May 13, 1994
REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8
K934638 · JOP
Cardiovascular · 231d
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