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

    SURGIC-ALERT MONITOR

    K Number: K930514 · Decision Aug 19, 1993
    View on FDA
    Classifications
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    80
    Applicant Total
    1
    Review Days
    199

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    Basic Information

    Device Name
    SURGIC-ALERT MONITOR
    K Number
    K930514
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Novatec Medical Products, Inc.--Glove Monitor
    Date Received
    February 1, 1993
    Decision Date
    August 19, 1993
    Product Code
    LDQ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

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