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

    Curbell branded Patient Monitoring Cables

    K Number: K182220 · Decision Nov 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    Curbell branded Patient Monitoring Cables
    K Number
    K182220
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Curbell Medical Products, Inc.
    Date Received
    August 15, 2018
    Decision Date
    November 7, 2018
    Product Code
    DSA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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