Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982651
    Device Name
    COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-12-11

    (134 days)

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

    COROMETRICS MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of the Model 5700 and 2264 Series Non-Invasive Watertight Transducers are indicated as accessories to Corometrics Fetal and Fetal/Maternal Monitors. The Model 5700 Watertight Transducer provides for the detection of fetal heart rate and the Model 2264 Watertight Transducer provides for the detection of uterine activity. Both transducers are intended to be used in either water or non-water environments. When used in water environment applications both transducers are intended to be directly connected to telemetry and not directly connected to a Fetal or Fetal Maternal monitor or any AC powered monitoring devices. Labeling and labels, on the transducers themselves, instruct the care provider to directly connect the transducers to a telemetry system when the devices are exposed to a water environment.
    Device Description
    The Model 5700 and 2264 Series Non-Invasive Watertight Transducers are intended as accessories to Corometrics' Fetal and Fetal/Maternal Monitors. The Model 5700 Series Transducer provides for the detection of fetal heart rate and the Model 2264 Series Transducer provides for the detection of uterine activity.
    Ask a Question

    Page 1 of 1