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

    NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL

    K Number: K042103 · Decision Aug 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    478
    Applicant Total
    5
    Review Days
    12

    Basic Information

    Device Name
    NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL
    K Number
    K042103
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MRI DEVICES CORPORATION
    Date Received
    August 4, 2004
    Decision Date
    August 16, 2004
    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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