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

    MAGNES 2500 WH BIOMAGNETOMETER

    K Number: K962317 · Decision May 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    8
    Review Days
    324

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    Basic Information

    Device Name
    MAGNES 2500 WH BIOMAGNETOMETER
    K Number
    K962317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomagnetic Technologies, Inc.
    Date Received
    June 17, 1996
    Decision Date
    May 7, 1997
    Product Code
    OLY
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OLY Magnetoencephalograph

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