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510(k) Data Aggregation

    K Number
    K201114
    Device Name
    Bidop 7
    Manufacturer
    Koven Technology, Inc.
    Date Cleared
    2021-01-05

    (253 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Koven Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bidop 7 is intended for the detection of arterial and venous blood flow in the extremities as well as fetal heart sounds. The Bidop 7 displays bi-directional velocity waverical data and fetal heart rate with heartbeat indicator. The Bidop 7 probe selection is 2, 5, 8, and 10 MHz.
    Device Description
    The Bidop 7 is designed to provide both qualitative and quantitative information. The qualitative information mainly includes color visual display of waveform's shapes, including qualitative analysis of Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms.
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    K Number
    K153762
    Device Name
    Smartdop XT6
    Manufacturer
    KOVEN TECHNOLOGY, INC.
    Date Cleared
    2016-05-25

    (147 days)

    Product Code
    JOP
    Regulation Number
    870.2880
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOVEN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smartdop XT6 is intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for ankle-brachial index (ABI), toe-brachial index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs, photoplethysmography (PPG) and/or Doppler probe. The optional foot temperature probe provides skin temperature readings on the foot. Collected data is captured and stored with Smart-XT-Link6 software that includes capabilities to print waveforms and export to into the facility's electronic health records. It is not intended to be used in fetal applications or used inside the sterile field. It is intended to be used by licensed healthcare practitioners on adults and pediatrics only.
    Device Description
    The Smartdop XT6 with Smart-XT-Link6 is designed to provide both qualitative information. The qualitative information mainly includes visual display of waveform's shapes, including qualitative analysis of Pulse Volume Recordings (PVR), Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms. Foot skin temperature readings are done with optional temperature probe and can be displayed in either Fahrenheit or Celsius. All tests controlled and stored by computer with Smart-XT-Link6 software for Windows OS with capabilities to print waveform data and export to electronic health record management systems.
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    K Number
    K143332
    Device Name
    Fast Sphyg by Koven
    Manufacturer
    KOVEN TECHNOLOGY, INC.
    Date Cleared
    2015-04-14

    (145 days)

    Product Code
    DXQ, DXO
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOVEN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a sphygmomanometer intended to be used with a stethoscope or Doppler for indirect measurement of arterial blood pressure. This device includes an aneroid gauge. Koven Technology, Inc. intends to provide the device for use by healthcare providers. Our product is for both hospital and clinical use and are intended for pediatric through adults, excluding neonates.
    Device Description
    The FAST Sphyg by Koven is an aneroid sphygmomanometer that uses the auscultatory blood pressure technique in combination with a stethoscope or Doppler and occluding cuff to determine systolic and diastolic blood pressure measurement. The FAST Sphyg includes an aneroid qauge, as well as a battery powered air pump so the user can control the inflation. When the activation button is pushed on the device, the air pump inflates the cuff. When the activation button is released, inflation stops, but the system remains pressurized. The aneroid gauge on the device reflects this increase in pressure, which is displayed in mmHg. A release valve is activated through a trigger switch to manually deflate the cuff and notate the blood pressure measurement.
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    K Number
    K131623
    Device Name
    SMARTDOP XT
    Manufacturer
    KOVEN TECHNOLOGY, INC.
    Date Cleared
    2014-01-17

    (227 days)

    Product Code
    JOP
    Regulation Number
    870.2880
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOVEN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smartdop XT is intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for ankle-brachial index (ABI), toe- brachial index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs and/or Doppler probe. The optional foot temperature provides skin temperature readings on the foot. Collected data is captured and stored with Smart-XT-Link software that includes capabilities to print waveforms and export to into the facility's electronic health records. It is not intended to be used in fetal applications or used inside the sterile field.
    Device Description
    The Smartdop XT with Smart-XT-Link is designed to provide both qualitative and quantitative information. The qualitative information mainly includes visual display of waveform's shapes. including qualitative analysis of Pulse Volume Recordings (PVR), Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms. Foot skin temperature readings are done with optional temperature probe and can be displayed in either Fahrenheit or Celsius. All tests controlled and stored by computer with Smart-XT-Link software for Windows OS with capabilities to print waveform data and export to electronic health record management systems.
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    K Number
    K080178
    Device Name
    VALVULOTOME BY KOVEN
    Manufacturer
    KOVEN TECHNOLOGY, INC.
    Date Cleared
    2008-07-28

    (186 days)

    Product Code
    MGZ
    Regulation Number
    870.4885
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOVEN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Valvulotome by Koven Valvulotome is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery.
    Device Description
    The Valvulotome by Koven is a medical device that has a deployable assembly with multiple deployable cutting blades and guide fins which permit continual centralizing, and alignment of the cutting blades within the lumen of the vein as the valves are being cut. The device includes a handle operatively associated with this deployable assembly through a catheter operated by the handle in a one-handed operation for deploying the guide fins and cutting blades of the deployable assembly having respective outer diameters at each deployment position. The Valvulotome by Koven consists of three main parts; the handle, the catheter and the cutter head.
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    K Number
    K050601
    Device Name
    SMARTDOP 45 VASCULAR DOPPLER
    Manufacturer
    KOVEN TECHNOLOGY, INC.
    Date Cleared
    2005-04-15

    (37 days)

    Product Code
    DPW, ITX, IYN
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOVEN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smartdop 45 detects arterial and venous blood flow in extremities as well as fetal heart rate. The Smartdop 45 displays and prints bi-directional velocity waveform, numerical data and fetal heart rate with heart beat indicator. The Smartdop 45 probe selection is 2, 4, 5, 8 and 10 MHz. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Peripheral Vascular. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.
    Device Description
    The Smartdop 45 is a hand held bi-directional Doppler is designed to obtain blood flow velocity. Ultrasound is transmitted from probe to patient and is reflected by the moving object (blood flow). The reflected ultrasound is received by the probe and is converted into electrical signals. The incoming Doppler Shifted signals are applied to the Velocity Circuity Circuits to remove unnecessary signals and to provide a bi-directional readout. This phase-shifting technique is a standard method employed in direction seeking Doppler, known for several decades. It continues in wide use. The waveform data are applied to the CPU for all the digital processing on LCD Display. The waveform data are applied to the off for the routing to the routing to the speaker to operate the analogue signals before digital processing. The LCD display can display combined bi-directionally separated waveforms. The printer can print out patient information and waveform. Integrated speaker provide Doppler sounds. A headset can be used, when is used it will mute the speaker. The following probes may be utilized with the Smartdop 45 Doppler: 1. 2 MHz for fetal heart rate 2. 4 MHz detections of arterial and venous blood flow velocity 3. 5 MHz detections of arterial and venous blood flow velocity 4. 8 MHz detections of arterial and venous blood flow velocity 5. 10 MHz detections of arterial and venous blood flow velocity The Smartdop 45 is intended for evaluation of the following: - Fetal Heart rate - ABI studies - PEAK & MEAN blood velocity determinations - Peripheral vascular procedures - Blood pressure segmental studies - Venous compressions - Penile & digit systolic pressures - Flow velocities in recovery room
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    K Number
    K031931
    Device Name
    ECHO SOUNDER EX-101EX 8 MHZ
    Manufacturer
    KOVEN TECHNOLOGY, INC.
    Date Cleared
    2004-02-13

    (235 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOVEN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Detection and displays blood velocity motion, peak velocity, mean velocity and heart rate. Evaluation of blood flow in patients with peripheral vascular disease, heart sounds and rates.
    Device Description
    The Echo Sounder ES-101EX 8M is a single-handed vascular Doppler system that utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within arteries and display heart rate. The unit amplifies the high frequency oscillation output and then supplies this to the transmitter transducer. The high frequency voltage is converted to ultrasound by the transducer and is transmitted to external objects. The ultrasound transmitted by the transducer movers straight through biophysical object(s), and is reflected by the moving object (fetal heartbeat etc.). The reflected ultrasound is received by the receiving transducer and is converted into electronic signals again. The converted electronic signals are amplified and then are detected. After removing unnecessary noise signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sound pressure through a speaker or a headset. Simultaneously the signals are applied to the heart rate LCD display.
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    K Number
    K031504
    Device Name
    ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
    Manufacturer
    KOVEN TECHNOLOGY, INC.
    Date Cleared
    2003-07-18

    (65 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOVEN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Detection of fetal life, detection of multiple pregnancies, fetal screens from early gestation through delivery and general indication of fetal well being. Verify fetal heart viability following patient trauma.
    Device Description
    The Echo Sounder ES-101EX Single-handed Fetal Doppler system utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within the fetal heart wall motion and arteries. The unit amplifies the high frequency oscillation output and then supplies this to the transmitter transducer. The high frequency voltage is converted to ultrasound by the transducer and is transmitted to external objects. The ultrasound transmitted by the transducer movers straight through biophysical object(s), and is reflected by the moving object (fetal heartbeat etc.). The reflected ultrasound is received by the receiving transducer and is converted into electronic signals again. The converted electronic signals are amplified and then are detected. After removing unnecessary noise signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sound pressure through a speaker or a headset. Simultaneously the signals are applied to the heart rate LCD display.
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    K Number
    K023143
    Device Name
    ECHO SOUNDER, ES-102EX
    Manufacturer
    KOVEN TECHNOLOGY, INC.
    Date Cleared
    2002-12-19

    (90 days)

    Product Code
    KNG
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOVEN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Detection of fetal heart rate, detection of multiple pregnancies. Verify fetal heart viability following patient trauma. Display of fetal heart rate, monitor fetal heart rate during labor.
    Device Description
    The Echo Sounder ES-102EX Fetal Doppler system utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within the fetal heart wall motion and arteries. The unit amplifies the high frequency oscillation output and then supplies this to the transmitter transducer. The high frequency voltage is converted to ultrasound by the transducer and is transmitted to external objects. The ultrasound transmitted by the transducer movers straight through biophysical object(s), and is reflected by the moving object (fetal heartbeat etc.). The reflected ultrasound is received by the receiving transducer and is converted into electronic signals again. The converted electronic signals are amplified and then are detected. After removing unnecessary noise signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sound pressure through a speaker or a headset. Simultaneously the signals are applied to the heart rate LCD display.
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    K Number
    K010452
    Device Name
    BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
    Manufacturer
    KOVEN TECHNOLOGY, INC.
    Date Cleared
    2002-02-12

    (362 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOVEN TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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