Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K081335
    Device Name
    TENACORE OXYGEN BLENDER, MODEL TB-2000
    Manufacturer
    TENACORE HOLDINGS, INC.
    Date Cleared
    2008-11-14

    (186 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    TENACORE HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tenacore Oxygen Blender, is intended for non-invasive mixing and delivery of a ratio of therapeutic oxygen and medical grade air as a stand-alone unit or as a component of a respiratory support apparatus.
    Device Description
    The Tenacore Oxygen Blender is typically a wall-mounted unit that provides inlets for medical grade air and therapeutic oxygen. The percentage of oxygen to air can be adjusted from 21-100%.
    Ask a Question
    K Number
    K053420
    Device Name
    TENACORE SP02 SENSORS
    Manufacturer
    TENACORE HOLDINGS, INC.
    Date Cleared
    2006-11-15

    (342 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    TENACORE HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Accessory to pulse oximeter for the purpose of continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
    Device Description
    SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in soft pad with a clear window. The sensor cable is terminated in a connector that couples with the corresponding monitor.
    Ask a Question
    K Number
    K043075
    Device Name
    TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
    Manufacturer
    TENACORE HOLDINGS, INC.
    Date Cleared
    2005-08-18

    (283 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    TENACORE HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These transducers are intended to be used as replacement accessories for Hewlett Packard and Corometrics fetal monitors. These transducers measure fetal heart rate or uterine contractions in the gravid patient.
    Device Description
    Tenacore Holdings, Inc. Transducers for Fetal Ultrasound and Tokodynamometer Monitoring are direct replacements for similar transducers manufactured by GE Marquette Medical Systems and Epic Medical Equipment Services. A Transducer employing ultrasound Doppler Shift Technology is used for the detection of Fetal Heart Rate during labor and a Tokodynamometer Transducer, which actually is a strain gauge, is used to evaluate and measure the duration, frequency, and relative pressure of uterine contractions during labor.
    Ask a Question
    K Number
    K012041
    Device Name
    THE HAMMER MODEL H100
    Manufacturer
    TENACORE HOLDINGS, INC.
    Date Cleared
    2002-03-28

    (272 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    TENACORE HOLDINGS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated in the compression of the femoral artery or vein after catherization.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1