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

    ARCHIMED 4210 AND 4220

    K Number: K973922 · Decision May 12, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    82
    Applicant Total
    20
    Review Days
    209

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    Basic Information

    Device Name
    ARCHIMED 4210 AND 4220
    K Number
    K973922
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosound Esaote, Inc.
    Date Received
    October 15, 1997
    Decision Date
    May 12, 1998
    Product Code
    LOS
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

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