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

    SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM

    K Number: K920294 · Decision Jul 7, 1992
    View on FDA
    Classifications
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    82
    Applicant Total
    2
    Review Days
    167

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    Basic Information

    Device Name
    SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM
    K Number
    K920294
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stuart Medical, Inc.
    Date Received
    January 22, 1992
    Decision Date
    July 7, 1992
    Product Code
    LOS
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

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