KOVEN TECHNOLOGY, INC.

FDA Device Registration & Listing · Saint Louis, MO, US · Registration 1937397

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1937397
FEI Number
1937397
Entity Name
KOVEN TECHNOLOGY, INC.
City/State/Country
Saint Louis, MO, US
Establishment Address
477 N Lindbergh Blvd, SUITE 220, Saint Louis, MO 63141, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
KOVEN TECHNOLOGY, INC. (Owner Number: 1937397)
Owner / Operator Contact Address
477 N. Lindbergh Blvd., STE 220, Saint Louis, MO 63141, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K840542
PMA Number
N/A

All Registered Proprietary Names

CT-6 CT-XT CT-4 CT-1 CT-2 CT-7 FAST Sphyg by Koven Smartdop XT6 PG-01 Smartdop 30EX PAUS2 HD307-8 HD307-20 HD307-10 AD8HD307 BiDop 3 PG-21 SmartVLiink Smartdop XT TP-01 PP8M05N5A BT8M05S8A P8M05S8A P10M5S8A T10M5S8C BP5M05S8A BF2M20S8A BF8M15S8A P5M05S8A T2M20S8C BT10M5S8C T5M05S8C BT2M20S8C T8M05S8C BP8M05S8A BT5M05S8 BT8M05S8C BT5M05S8A BP10M5S8A PP10M5N5A VDP-8 VRP-08 NRP-10H CRP-10H NDP-10 NP20M12S8AF HP20M1N5AF FDP-8 HP10M2N5AF CRP-20H CRP-20H1N NP20M12SF11 NP20M1S8A NP10M2S8AF VDP-08A NRP-20H LRP-08 ACP-08 NDP-20 VRP-20 Smartdop 45 ES100X

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment) Anesthesiology Class 1 868.6175 2017-12-14
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2015-04-20
JOP Transducer, Ultrasonic Cardiovascular Class 2 870.2880 2017-12-14
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2007-11-20
LMD System, Digital Image Communications, Radiological Radiology Class 1 892.2020 2024-12-24
JOP Transducer, Ultrasonic Cardiovascular Class 2 870.2880 2007-11-20
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2007-11-20
JOP Transducer, Ultrasonic Cardiovascular Class 2 870.2880 2007-11-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2007-11-20
JOP Transducer, Ultrasonic Cardiovascular Class 2 870.2880 2017-12-14
JOP Transducer, Ultrasonic Cardiovascular Class 2 870.2880 2007-11-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2007-11-20
JAF Monitor, Ultrasonic, Nonfetal Radiology Class 2 892.1540 2007-11-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2007-11-20
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2007-11-20
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2007-11-20
JOP Transducer, Ultrasonic Cardiovascular Class 2 870.2880 2017-12-14

Official Correspondent

HEATHER BELL

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KOVEN TECHNOLOGY, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K831001 Frontier Products UNICUFF-BLOOD PRESSURE CUFF 1983-07-28
K253089 Shenzhen Best Electronics Co., Ltd. NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) 2026-02-13
K972301 Rudolf Riester GmbH & Co. KG BIG BEN SQUARE, BIG BEN ROUND 1997-09-17
K903633 Transonic Systems, Inc. ADVANCE LASER FLOWMETER, ALF 21 1990-10-09
K182494 Laser Associated Sciences, Inc. FlowMet-R 2019-02-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011 Verathon, Inc. 2
AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011 Verathon, Inc. 2
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014 SonoSite, Inc. 2
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1937397. Last updated year: 2026. Please use registration number 1937397 when referencing this establishment in official correspondence.
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