BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING

    K Number: K131860 · Decision Sep 27, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    71
    Applicant Total
    1
    Review Days
    95

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    Basic Information

    Device Name
    VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING
    K Number
    K131860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2880
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Us Vascular, LLC
    Date Received
    June 24, 2013
    Decision Date
    September 27, 2013
    Product Code
    JOP
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOP Transducer, Ultrasonic

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