Company ยท US
Koven Technology, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2021. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
1recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 5, 2021 | K201114 | Bidop 7 Koven Technology, Inc. | DPW |
| May 25, 2016 | K153762 | Smartdop XT6 Koven Technology, Inc. | JOP |
| Apr 14, 2015 | K143332 | Fast Sphyg by Koven Koven Technology, Inc. | DXQ |
| Jan 17, 2014 | K131623 | SMARTDOP XT Koven Technology, Inc. | JOP |
| Jul 28, 2008 | K080178 | VALVULOTOME BY KOVEN Koven Technology, Inc. | MGZ |
| Apr 15, 2005 | K050601 | SMARTDOP 45 VASCULAR DOPPLER Koven Technology, Inc. | DPW |
| Feb 13, 2004 | K031931 | ECHO SOUNDER EX-101EX 8 MHZ Koven Technology, Inc. | DPW |
| Jul 18, 2003 | K031504 | ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX Koven Technology, Inc. | KNG |
| Dec 19, 2002 | K023143 | ECHO SOUNDER, ES-102EX Koven Technology, Inc. | KNG |
| Feb 12, 2002 | K010452 | BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T Koven Technology, Inc. | DPW |
| Nov 24, 1998 | K982986 | TUBING BLOOD FLOW METER MODEL NUMBER HD-800 Koven Technology, Inc. | DPW |
| Jul 23, 1997 | K961817 | B SMART MODEL 1 Koven Technology, Inc. | LEL |
| Oct 31, 1996 | K963274 | V-LINK 3.2 FOR WINDOWS Koven Technology, Inc. | IYO |
| May 20, 1996 | K951449 | MODEL KM-25 Koven Technology, Inc. | IYO |
| Mar 29, 1996 | K954397 | BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY Koven Technology, Inc. | DPW |
| May 11, 1995 | K935994 | PW DOPPLER VASCULAR PROBES Koven Technology, Inc. | ITX |
| Dec 23, 1994 | K942613 | SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR Koven Technology, Inc. | DPW |
| May 13, 1994 | K934638 | REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8 Koven Technology, Inc. | JOP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | Koven Technology, Inc. Brand Name: BiDop 3
Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe
Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe).
Software Version: N/A
Product Des Open, Classified |
DPW | K954397 |