BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    RFP-100A Connector Cable (Single Use)

    K Number: K230571 · Decision May 30, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    RFP-100A Connector Cable (Single Use)
    K Number
    K230571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baylis Medical Technologies, Inc.
    Date Received
    March 1, 2023
    Decision Date
    May 30, 2023
    Product Code
    DSA
    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
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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