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510(k) Data Aggregation

    K Number
    K061044
    Device Name
    FEATHERLITE AQUA TOCODYNAMOMETER
    Manufacturer
    VENTREX, INC.
    Date Cleared
    2006-07-12

    (89 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Why did this record match?
    Applicant Name (Manufacturer) :

    VENTREX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FeatherLite Aqua™Toco dynamometer is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. Is should only be used in a clinical setting. It may be fully submerged in water for water birthing or monitoring in a whirlpool. Caution: FeatherLite Aqua™Toco is not intended for home monitoring of pre-term labor. Placement over the fundal area of the uterus to the left or right of the midline is suitable for most patients, It is held on the surface of the abdomen using a standard button hole or Velcro™ type belt. The product is supplied non-sterile and is intended for single use only.
    Device Description
    The FeatherLite Aqua™ tocodynamometer (toco) is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods in a clinical setting. The fetal monitor is not intended for home monitoring or pre-term labor. It can be used in both dry and fully submerged environments It is held in place on the surface of the abdomen using an elastic belt. It is sold non-sterile and is intended for single use only.
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    K Number
    K013477
    Device Name
    TOCO LITE, MODEL TD-01
    Manufacturer
    VENTREX, INC.
    Date Cleared
    2002-01-17

    (90 days)

    Product Code
    HFM
    Regulation Number
    884.2720
    Why did this record match?
    Applicant Name (Manufacturer) :

    VENTREX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FeatherLite Toco tocodynamometer is intended for use in conjunction with standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. It should only be used in a clinical setting. Caution: The FeatherLife Toco is not intended for home monitoring of pre-term labor. Placement over the fundal area of the uterus to the left or right of the midline is suitable for most patients. It is held in place on the surface of the abdomen using the attached elastic belt.
    Device Description
    The FeatherLite Toco is generally rectangular in shape with a domed sensor body and nipple-like appendage. It includes a belt to hold it on the patient. The device is lower profile and significantly lighter than standard tocos. The rectangular base and dome sensor body are molded from thermoplastic. The sensing nipple is formed from a flexible polymer. The sensor is a strain gauge. The cable is a jacketed array of four individually insulated wires. The belt is an elastic nylon webbing.
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    K Number
    K964821
    Device Name
    COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67
    Manufacturer
    VENTREX, INC.
    Date Cleared
    1997-07-16

    (226 days)

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

    VENTREX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COVERox Sheath is intended for use in conjunction with reusable pulse oximetry finger tip probes of the "clothes pin" style (these probes are generally placed onto finger tips only). It provides a gross contamination barrier when properly installed. It does not provide a sterile covering or a fluid tight covering and should not be used in lieu of sterilizing a reusable probe in situations where a sterile probe is indicated. It should be used to reduce the time and effort required to clean the reusable probe between uses by minimizing the probe exposure to gross contamination. The COVERox Sheath is supplied non-sterile and is intended for single use only.
    Device Description
    Not Found
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