BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil

    K Number: K213480 · Decision Feb 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    7
    Review Days
    460

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    Basic Information

    Device Name
    31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
    K Number
    K213480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rapid Biomedical GmbH
    Date Received
    October 29, 2021
    Decision Date
    February 1, 2023
    Product Code
    MOS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MOS Coil, Magnetic Resonance, Specialty

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